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A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

Primary Purpose

Low-grade Serous Ovarian Cancer, Low-grade Serous Fallopian Tube Cancer, Low-grade Serous Peritoneal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MEK162, MEK inhibitor; oral
Physician's choice chemotherapy
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-grade Serous Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma), confirmed histologically and verified by central pathology review.
  • Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician.
  • Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows.
  • Available archival tumor sample (excisional or core biopsy) for confirmation of LGS carcinoma diagnosis. If adequate archival tumor sample is not available, willingness to consent to tissue biopsy.
  • Suitable for treatment with at least one of the physician's choice chemotherapy options (liposomal doxorubicin, paclitaxel or topotecan) as determined by the Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Additional criteria exist.

Key Exclusion Criteria:

  • History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
  • Prior therapy with a MEK or BRAF inhibitor.
  • History of Gilbert's syndrome.
  • Impaired cardiovascular function or clinically significant cardiovascular diseases.
  • Uncontrolled or symptomatic brain metastases that are not stable or require steroids, are potentially life-threatening or have required radiation within 28 days prior to first dose of study treatment.
  • Concomitant malignancies or previous malignancies with less than a 5-year disease-free interval at the time of first dose of study treatment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of diagnosis.
  • Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or active hepatitis C.
  • Prior randomization into this clinical study.
  • Additional criteria exist.

Sites / Locations

  • University of Arizona Cancer Center
  • Associated Retina Consultants, Ltd.
  • Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology
  • Keck Hospital of USC
  • LAC & USC Medical Center
  • USC Healthcare Consultation Center 1
  • USC Healthcare Consultation Center 2
  • USC Norris Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center
  • Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology
  • Doris Stein Research Center Building
  • University of California Los Angeles, Hematology-Oncology Clinic
  • Gynecologic Oncology Associates
  • University of California, Irvine/UC Irvine Health
  • UCLA Hematology/Oncology Clinic - Santa Monica
  • UCLA Hematology Oncology Clinic Santa Clarita
  • UCLA Hematology - Oncology Clinic - Westlake Village
  • Rocky Mountain Lions Eye Institute
  • University of Colorado Cancer Center
  • University of Colorado Denver, University of Colorado Cancer Center
  • Smilow Cancer Hospital at Yale-New Haven
  • Eye Physicians of Central Florida
  • Florida Hospital
  • Florida Hospital Cancer Institute
  • Eye Physicians of Central
  • H. Lee Moffitt Cancer Center and Research Institute
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Georgia Regents University Cancer Center
  • University of Chicago Medical Center
  • St. Vincent Cancer Care
  • St. Vincent Gynecologic Oncology
  • St. Vincent Gynecology Oncology
  • St. Vincent Hospital and Health Care Center, Inc.
  • Associated Vitreoretinal and Uveitis Consultants
  • University of Iowa Hospitals and Clinics
  • University of Maryland Greenebaum Cancer Center
  • Massachusetts General Hospital
  • Ophthalmic Consultants of Boston (OCB)
  • Karmanos Cancer Institute
  • Kresge Eye Institute
  • Karmanos Cancer Institute
  • Barnes-Jewish Hospital
  • Center for Advanced Medicine
  • Center For Clinical Studies
  • Washington University
  • Billings Clinic
  • University of New Mexico Cancer Center
  • Eye Associates of New Mexico
  • Montefiore Medical Center - Einstein Center for Cancer Care
  • Montefiore Medical Center
  • Montefiore Medical Center - Centennial Women's Health
  • Montefiore Medical Center, Green Medical Arts Pavilion
  • Memorial Sloan Kettering Cancer Center
  • University of Cincinnati Medical Center
  • Fairview Hospital Moll Pavilion Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Cleveland Clinic-Main Campus
  • James Cancer Hospital & Solove Research Institute
  • OSU Wexner Medical Center
  • Stefanie Spielman Comprehensive Breast Cancer
  • OSU Gynecologic Oncology at Mill Run
  • Hillcrest Hospital
  • University of Cincinnati Physicians Company
  • Dean McGee Eye Institute
  • Stephenson Cancer Center(clinic location)
  • Stephenson Cancer Center
  • Fox Chase Cancer Center
  • Jeanes Hospital
  • Magee-Womens Hospital of UPMC
  • University of Pittsburgh Medical Center
  • Parkland Health and Hospital System
  • UT Southwestern Medical Center-Zale Lipshy University Hospital
  • UT Southwestern Medical Center-Clements University Hospital
  • UT Southwestern Medical Center
  • University of Texas MD Anderson Cancer Center
  • University of Virginia
  • Dr Anil Arora
  • Sydney Adventist Hospital
  • Westmead Hospital
  • Mater Misericordiae Health Services Brisbane Limited
  • Adelaide Cardiology
  • Adelaide Eye and Retina Centre
  • Royal Adelaide Hospital
  • Thomas and Delaney Optometrists
  • Burnside War Memorial Hospital
  • Sunshine Hospital
  • Sir Charles Gairdner Hospital
  • Innsbruck Medical University
  • Centre Hospitalier de l'ardenne
  • Private practice Ophthalmology
  • University Hospital Leuven
  • Cliniques Universitaires Saint-Luc
  • Ghent University Hospital
  • University Hospital Gent
  • CHR de la Citadelle
  • Clinique et Maternite Sainte-Elisabeth Namur
  • Sint-Augustinus
  • Tom Baker Cancer Centre
  • British Columbia Cancer Agency - Vancouver Centre
  • CancerCare Manitoba
  • Juravinski Cancer Center, Department of Oncology
  • Princess Margaret Cancer Centre
  • Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame
  • Jewish General Hospital
  • Teaching Hospital Hradec Kralove
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Ostrava
  • Fakultni Nemocnice Ostrava
  • Fakultni nemocnice Ostrava
  • General University Hospital in Prague
  • General University Hospital in Prague
  • Aalborg Sygehus Apotek
  • Aalborg University Hospital
  • Herlev Hospital Onkologisk AFD
  • Region Hovedstadens Apotek
  • Rigshospitalet
  • Ojenklinikken 2061
  • Radiologisk Afdeling 2023
  • Tampere University Hospital
  • CHU Jean Minjoz
  • Centre Oscar Lambret
  • Hopital Prive La Louviere
  • Centre Leon Berard
  • Hopital Edouard Herriot
  • Institut Paoli Calmettes - Departement d'Oncologie Medicale
  • Centre Paradis Monticelli
  • Centre d'Ophtalmologie du LEZ Centre Medical Les Roques
  • Institut Regional du Cancer Montpellier
  • L'Hopital Prive du Confluent SAS
  • Cabinet Liberal du Dr Xavier Zanlonghi
  • Clinique Sourdille
  • Hopital Europeen Georges Pompidou
  • Centre d'Investigations Cliniques 1423
  • Centre Investigateur CARIO - HPCA
  • Institut de Cancerologie de I'Ouest - Rene Gauducheau
  • Institut Gustave Roussy
  • Universitaets-Brustzentrum
  • Universitätsfrauenklinik Ulm
  • Klinikum rechts der Isar
  • Klinik fur Frauenheilkunde und Geburtshilfe
  • Kliniken Essen-Mitte
  • Universitätsklinikum Bonn
  • Uni Carl Gustav Carus
  • Universitätsklinikum Schleswig-Holstein
  • Charité Universitaetsmedizin Berlin
  • Universitaetsklinik Freiburg
  • Frauenheilkunde und Geburtshilfe
  • NCT Nationales Centrum für Tumorerkrankungen Heidelberg
  • Euromedic Diagnostics Magyarorszag Kft.
  • Petz Aladar Korhaz Kardiologiai Osztaly
  • Petz Aladar Korhaz Szemeszeti Osztaly
  • Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Semmelweis Egyetem AOK Szemeszeti Klinika
  • Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly
  • Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
  • Orszagos Onkologiai Intezet
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • St James's Hospital
  • Istituto Clinico Humanitas
  • Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C
  • Ospedale Civile degli Infermi - Servizio di Oculistica
  • Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica
  • Ospedale Umberto I - Unita Operativa di Oncologia
  • Istituto Nazionale Tumori Regina Elena - Oncologia Medica A
  • Policlinico Umberto I - Università Sapienza
  • Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica
  • SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi
  • Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi
  • Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica
  • Spedali Civili Di Brescia
  • Azienda Ospedaliera Cannizzaro
  • Ospedale San Raffaele - Unita Operativa di Oculistica
  • Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica
  • Istituto Europeo Oncologico
  • Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica
  • Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico
  • Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze
  • Universita degli Studi Federico II di Napoli Oncologia Medica
  • Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -
  • Ospedale Santa Maria delle Croci - Oculistica
  • Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia
  • Dipartimento Organi di Senso
  • Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica
  • Policlinico Agostino Gemelli
  • Academic Medical Center (AMC)
  • University Medical Center Groningen, Medical Oncology
  • Maastricht University Medical Centre
  • Aleris
  • Avd. for gynekologisk kreft, Radiumhospitalet
  • Oslo Universitetssykehus HF
  • Centralny Szpital Kliniczny MON
  • Hospital Duran i Reynals
  • Hospital Universitario Reina Sofía/ Provincial
  • Centro de Salud Anoeta
  • Hospital Universitario Donostia
  • Ophthalmology at Instituto Oftalmologico Integral
  • Hospital Clinic Barcelona
  • Hospital de Sant Joan Despi Moises Broggi
  • Cardiology at Consulta de Cardiologia
  • Centro Medico Sanitas Ressalta
  • Instituto de Oftalmologia y Hospital La Arruzafa
  • Radiology at Centro Medico Sanitas Ressalta
  • Radiology at Hospital Univeristari de Bellvitge
  • Hospital Ramón Y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Son Llatzer
  • Hospital Universitario Virgen Macarena
  • Hospital Virgen de la Salud
  • Fundacion IVO-Instituto Valenciano de Oncologia
  • Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia
  • Karolinska Universitetssjukhuset
  • Onkologkliniken Akademiska Sjukhuset
  • Sarah Cannon Research Institute UK
  • Nottingham University Hospitals NHS Trust
  • University of Nottingham
  • Ashtead Hospital
  • The Clock House Medical Practice
  • The Royal Marsden NHS Foundation Trust
  • St. Anthony's Hospital
  • City Hospital
  • Royal Marsden NHS Foundation Trust
  • The Harley Street Clinic
  • London Eye Diagnostic Centre
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MEK162

Physician's choice chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (>=) 5 millimeter (mm). Appearance of new lesions >=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.

Secondary Outcome Measures

Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants who were alive at the data cutoff date were censored for overall survival at their last contact date.
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease.
Duration of Response (DOR)
DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy.
Disease Control Rate
Disease control rate was defined as percentage of participants with disease control. Disease control was defined as a best response of CR or PR, or stable disease (SD) documented at Week 24 or later. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm, and PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3
Number of participants with shifts from normal Baseline values (Grade 0) to abnormal post-baseline values (shift to greater than or equal to Grade 3) were reported as per NCI-CTCAE, V4.3 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Shifts in lab parameter from Grade 0 to 3, Grade 0 to 4 and Grade 0 to Low 3 and 4 and Grade 0 to High 3 and 4 (for parameters total hemoglobin, lymphocytes, white blood cells, calcium, magnesium, potassium, and sodium) were reported.

Full Information

First Posted
May 6, 2013
Last Updated
November 1, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01849874
Brief Title
A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
Official Title
The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2013 (Actual)
Primary Completion Date
January 20, 2016 (Actual)
Study Completion Date
August 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-grade Serous Ovarian Cancer, Low-grade Serous Fallopian Tube Cancer, Low-grade Serous Peritoneal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
341 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEK162
Arm Type
Experimental
Arm Title
Physician's choice chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MEK162, MEK inhibitor; oral
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Physician's choice chemotherapy
Intervention Description
Patients will receive one of the following chemotherapies as determined by the physician: Liposomal doxorubicin, anthracycline antibiotic; intravenous (multiple dose, single schedule) Paclitaxel, mitotic inhibitor; intravenous (multiple dose, single schedule) Topotecan, topoisomerase 1 inhibitor; intravenous (multiple dose, single schedule)
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Description
PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (>=) 5 millimeter (mm). Appearance of new lesions >=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.
Time Frame
From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death due to any cause. Participants who were alive at the data cutoff date were censored for overall survival at their last contact date.
Time Frame
From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)
Title
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
Description
ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease.
Time Frame
From randomization until disease progression or death (up to 24 months)
Title
Duration of Response (DOR)
Description
DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy.
Time Frame
From the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months)
Title
Disease Control Rate
Description
Disease control rate was defined as percentage of participants with disease control. Disease control was defined as a best response of CR or PR, or stable disease (SD) documented at Week 24 or later. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm, and PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study.
Time Frame
Week 24
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
From the first dose of study drug until 30 days after the last dose (up to 25 months)
Title
Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3
Description
Number of participants with shifts from normal Baseline values (Grade 0) to abnormal post-baseline values (shift to greater than or equal to Grade 3) were reported as per NCI-CTCAE, V4.3 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Shifts in lab parameter from Grade 0 to 3, Grade 0 to 4 and Grade 0 to Low 3 and 4 and Grade 0 to High 3 and 4 (for parameters total hemoglobin, lymphocytes, white blood cells, calcium, magnesium, potassium, and sodium) were reported.
Time Frame
From the first dose of study drug until 30 days after the last dose (up to 25 months)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma), confirmed histologically and verified by central pathology review. Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician. Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows. Available archival tumor sample (excisional or core biopsy) for confirmation of LGS carcinoma diagnosis. If adequate archival tumor sample is not available, willingness to consent to tissue biopsy. Suitable for treatment with at least one of the physician's choice chemotherapy options (liposomal doxorubicin, paclitaxel or topotecan) as determined by the Investigator. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Additional criteria exist. Key Exclusion Criteria: History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes). Prior therapy with a MEK or BRAF inhibitor. History of Gilbert's syndrome. Impaired cardiovascular function or clinically significant cardiovascular diseases. Uncontrolled or symptomatic brain metastases that are not stable or require steroids, are potentially life-threatening or have required radiation within 28 days prior to first dose of study treatment. Concomitant malignancies or previous malignancies with less than a 5-year disease-free interval at the time of first dose of study treatment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of diagnosis. Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or active hepatitis C. Prior randomization into this clinical study. Additional criteria exist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Associated Retina Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
LAC & USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Healthcare Consultation Center 1
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Healthcare Consultation Center 2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Doris Stein Research Center Building
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Los Angeles, Hematology-Oncology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Gynecologic Oncology Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California, Irvine/UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCLA Hematology/Oncology Clinic - Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Hematology Oncology Clinic Santa Clarita
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
UCLA Hematology - Oncology Clinic - Westlake Village
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Rocky Mountain Lions Eye Institute
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Denver, University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Eye Physicians of Central Florida
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Eye Physicians of Central
City
Orlando
State/Province
Florida
ZIP/Postal Code
32835
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Florida Cancer Specialists
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Georgia Regents University Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
St. Vincent Cancer Care
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
St. Vincent Gynecologic Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
St. Vincent Gynecology Oncology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
St. Vincent Hospital and Health Care Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Associated Vitreoretinal and Uveitis Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ophthalmic Consultants of Boston (OCB)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Karmanos Cancer Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center For Clinical Studies
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Montefiore Medical Center - Einstein Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center - Centennial Women's Health
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Medical Center, Green Medical Arts Pavilion
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Fairview Hospital Moll Pavilion Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic-Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
James Cancer Hospital & Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OSU Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Stefanie Spielman Comprehensive Breast Cancer
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
OSU Gynecologic Oncology at Mill Run
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Facility Name
Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
University of Cincinnati Physicians Company
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Stephenson Cancer Center(clinic location)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Jeanes Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern Medical Center-Zale Lipshy University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern Medical Center-Clements University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Dr Anil Arora
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Misericordiae Health Services Brisbane Limited
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Adelaide Cardiology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Adelaide Eye and Retina Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Thomas and Delaney Optometrists
City
Norwood
State/Province
South Australia
ZIP/Postal Code
5067
Country
Australia
Facility Name
Burnside War Memorial Hospital
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Innsbruck Medical University
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Centre Hospitalier de l'ardenne
City
Libramont
State/Province
Luxembourg
ZIP/Postal Code
6800
Country
Belgium
Facility Name
Private practice Ophthalmology
City
Libramont
State/Province
Luxembourg
ZIP/Postal Code
6800
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
State/Province
Vlaams-brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Ghent University Hospital
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique et Maternite Sainte-Elisabeth Namur
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Juravinski Cancer Center, Department of Oncology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Teaching Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
General University Hospital in Prague
City
Prague 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Aalborg Sygehus Apotek
City
Aalborg
State/Province
North Jutland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
North Jutland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Herlev Hospital Onkologisk AFD
City
Herlev
ZIP/Postal Code
02730
Country
Denmark
Facility Name
Region Hovedstadens Apotek
City
Kobenhavn o
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Rigshospitalet
City
Kobenhavn o
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Ojenklinikken 2061
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Radiologisk Afdeling 2023
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
FI-33251
Country
Finland
Facility Name
CHU Jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Prive La Louviere
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Leon Berard
City
LYON Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Institut Paoli Calmettes - Departement d'Oncologie Medicale
City
Marseille Cedex 09
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Paradis Monticelli
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre d'Ophtalmologie du LEZ Centre Medical Les Roques
City
Montferrier S/lez
ZIP/Postal Code
34980
Country
France
Facility Name
Institut Regional du Cancer Montpellier
City
Montpellier CEDEX 5
ZIP/Postal Code
34298
Country
France
Facility Name
L'Hopital Prive du Confluent SAS
City
NANTES Cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Cabinet Liberal du Dr Xavier Zanlonghi
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Clinique Sourdille
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Centre d'Investigations Cliniques 1423
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre Investigateur CARIO - HPCA
City
Plerin
ZIP/Postal Code
22190
Country
France
Facility Name
Institut de Cancerologie de I'Ouest - Rene Gauducheau
City
Saint-Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaets-Brustzentrum
City
Tuebingen
State/Province
Baden-wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsfrauenklinik Ulm
City
Ulm
State/Province
Baden-wurttemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
Klinikum rechts der Isar
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinik fur Frauenheilkunde und Geburtshilfe
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34125
Country
Germany
Facility Name
Kliniken Essen-Mitte
City
Essen
State/Province
North Rhine-westphalia
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
North-rhine Westphalia
ZIP/Postal Code
53127
Country
Germany
Facility Name
Uni Carl Gustav Carus
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charité Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Frauenheilkunde und Geburtshilfe
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
NCT Nationales Centrum für Tumorerkrankungen Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Euromedic Diagnostics Magyarorszag Kft.
City
Gyor
State/Province
Gyor-moson-sopron
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Petz Aladar Korhaz Kardiologiai Osztaly
City
Gyor
State/Province
Gyor-moson-sopron
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Petz Aladar Korhaz Szemeszeti Osztaly
City
Gyor
State/Province
Gyor-moson-sopron
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem AOK Szemeszeti Klinika
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
St James's Hospital
City
Dublin
State/Province
Dublin 8
Country
Ireland
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale Civile degli Infermi - Servizio di Oculistica
City
Faenza
State/Province
Ravenna
ZIP/Postal Code
48018
Country
Italy
Facility Name
Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica
City
Faenza
State/Province
Ravenna
ZIP/Postal Code
48018
Country
Italy
Facility Name
Ospedale Umberto I - Unita Operativa di Oncologia
City
Lugo
State/Province
Ravenna
ZIP/Postal Code
48022
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena - Oncologia Medica A
City
Roma
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Facility Name
Policlinico Umberto I - Università Sapienza
City
Roma
State/Province
Rome
ZIP/Postal Code
00155
Country
Italy
Facility Name
Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica
City
Roma
State/Province
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Spedali Civili Di Brescia
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Azienda Ospedaliera Cannizzaro
City
Catania
ZIP/Postal Code
95216
Country
Italy
Facility Name
Ospedale San Raffaele - Unita Operativa di Oculistica
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo Oncologico
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita degli Studi Federico II di Napoli Oncologia Medica
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -
City
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci - Oculistica
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Dipartimento Organi di Senso
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Policlinico Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Academic Medical Center (AMC)
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1150 AZ
Country
Netherlands
Facility Name
University Medical Center Groningen, Medical Oncology
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Aleris
City
Oslo
ZIP/Postal Code
0264
Country
Norway
Facility Name
Avd. for gynekologisk kreft, Radiumhospitalet
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Oslo Universitetssykehus HF
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Centralny Szpital Kliniczny MON
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Reina Sofía/ Provincial
City
Córdoba
State/Province
Castilla LA Mancha
ZIP/Postal Code
14004
Country
Spain
Facility Name
Centro de Salud Anoeta
City
Anoeta
State/Province
Guipuzcoa
ZIP/Postal Code
20270
Country
Spain
Facility Name
Hospital Universitario Donostia
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Ophthalmology at Instituto Oftalmologico Integral
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Sant Joan Despi Moises Broggi
City
Barcelona
ZIP/Postal Code
08970
Country
Spain
Facility Name
Cardiology at Consulta de Cardiologia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Centro Medico Sanitas Ressalta
City
Cordoba
ZIP/Postal Code
14012
Country
Spain
Facility Name
Instituto de Oftalmologia y Hospital La Arruzafa
City
Cordoba
ZIP/Postal Code
14012
Country
Spain
Facility Name
Radiology at Centro Medico Sanitas Ressalta
City
Cordoba
ZIP/Postal Code
14012
Country
Spain
Facility Name
Radiology at Hospital Univeristari de Bellvitge
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Fundacion IVO-Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Onkologkliniken Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
England
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
University of Nottingham
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Ashtead Hospital
City
Ashtead
State/Province
Surrey
ZIP/Postal Code
KT21 2SB
Country
United Kingdom
Facility Name
The Clock House Medical Practice
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7LX
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
St. Anthony's Hospital
City
North Cheam
State/Province
Sutton
ZIP/Postal Code
SM3 9Dw
Country
United Kingdom
Facility Name
City Hospital
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Harley Street Clinic
City
London
ZIP/Postal Code
W1G 8PP
Country
United Kingdom
Facility Name
London Eye Diagnostic Centre
City
London
ZIP/Postal Code
W1G 9QN
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
32822286
Citation
Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. doi: 10.1200/JCO.20.01164. Epub 2020 Aug 21.
Results Reference
derived

Learn more about this trial

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

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