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Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gemcitabine (Chemotherapy)
Paclitaxel (Chemotherapy)
Pertuzumab
Placebo
Topotecan (Chemotherapy)
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, and/or fallopian tube cancer that is platinum-resistant or refractory
  • Low Human epidermal growth factor receptor (HER) 3 messenger ribonucleic acid (mRNA) expression
  • At least one measurable and/or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
  • Negative serum pregnancy test in women of childbearing potential
  • Women of childbearing potential must agree to use effective contraception as defined by protocol during and for at least 6 months post study treatment

Exclusion Criteria:

  • Non-epithelial tumors
  • Ovarian tumors with low malignant potential (borderline tumors)
  • History of other malignancy of prognostic relevance within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma, or tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the breast
  • Previous treatment with more than 2 chemotherapy regimens
  • Any prior radiotherapy to the pelvis or abdomen
  • History or evidence on physical/neurological examination of central nervous system disease unrelated to cancer (uncontrolled seizures), unless adequately treated with standard medical therapy
  • Pre-existing peripheral neuropathy >/= common toxicity criteria (CTC) grade 2 (applicable for paclitaxel cohort only)
  • Inadequate organ function
  • Uncontrolled hypertension or clinically significant cardiovascular disease
  • Current known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • Current chronic daily treatment with corticosteroids (>/= 10 mg per day of methylprednisolone or equivalent), excluding inhaled steroids
  • History of receiving any investigational treatment within 28 days prior to first study drug administration
  • For Part 2 of the trial: prior enrollment into Part 1 of the trial
  • Concurrent participation in any therapeutic clinical trial

Sites / Locations

  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  • Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
  • UZ Leuven Gasthuisberg
  • Herlev Hospital; Onkologisk afdeling
  • Rigshospitalet, Onkologisk Klinik
  • Institut Bergonie; Oncologie
  • Centre Francois Baclesse; Oncologie
  • Centre Georges Francois Leclerc; Oncologie 3
  • CRLCC Val dAurelle Paul Lam
  • Hopital Tenon; Oncologie Radiotherapie
  • Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont
  • Clinique Armoricaine Radiologie; Hopital de Jour
  • Ico Rene Gauducheau; Oncologie
  • Centre Alexis Vautrin; Oncologie Medicale
  • Institut Gustave Roussy; Oncologie Medicale
  • Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
  • Evangelischen Krankenhauses Düsseldorf; Frauenklinik
  • Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
  • Universitätsklinikum Freiburg; Frauenklinik
  • Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
  • Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
  • Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  • UNI-Klinikum Campus Kiel Klinik f.Gynäkologie u.Geburtshilfe
  • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
  • Klinikum Konstanz, Frauenklinik
  • Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
  • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
  • Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum
  • Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
  • Universitätsklinik Tübingen; Frauenklinik
  • Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
  • Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
  • Istituto Regina Elena; Oncologia Medica A
  • Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
  • A.O.Spedali Civili; Ostetricia e Ginecologia
  • Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
  • Istituto Europeo Di Oncologia
  • A.O.U Pisana; Dipartimento di Ginecologia Oncologica
  • Antoni van Leeuwenhoek Ziekenhuis
  • Academ Ziekenhuis Groningen; Medical Oncology
  • Academisch Ziekenhuis Leiden; Clinical Oncology
  • UMC St Radboud
  • The Norvegian Radium Hospital Montebello; Dept of Oncology
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Son Llatzer; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Hospital Duran i Reynals; Oncologia
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
  • Instituto Valenciano Oncologia; Oncologia Medica
  • Hospital Universitario la Fe; Servicio de Oncologia
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Universitetssjukhuset; Onkologkliniken
  • Skånes University Hospital, Skånes Department of Onclology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1: Pertuzumab + Topotecan

Part 1: Pertuzumab + Paclitaxel

Part 2: Pertuzumab+Chemotherapy

Part 2: Placebo+Chemotherapy

Arm Description

Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.

Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.

Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.

Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.

Outcomes

Primary Outcome Measures

Part 1: Percentage of Participants With Adverse Events (AEs)
An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)
PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

Part 1- Objective Response Rate (ORR)
ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Part 2- Objective Response Rate (ORR)
ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Part 1: PFS Assessed by the Investigator
PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day.
Part 2: Progression-free Survival (PFS) Assessed by the Investigator
PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.
Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life.
Part 2: Percentage of Participants With Adverse Events (AEs)
An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Part 2: Overall Survival
Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause

Full Information

First Posted
September 11, 2012
Last Updated
April 13, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01684878
Brief Title
Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)
Official Title
A Two-Part, Randomized Phase III, Double-Blind, Multicenter Trial Assessing The Efficacy And Safety of Pertuzumab In Combination With Standard Chemotherapy Vs. Placebo Plus Standard Chemotherapy In Women With Recurrent Platinum-Resistant Epithelial Ovarian Cancer And Low HER3 mRNA Expression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 22, 2012 (Actual)
Primary Completion Date
January 30, 2015 (Actual)
Study Completion Date
April 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Pertuzumab + Topotecan
Arm Type
Experimental
Arm Description
Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
Arm Title
Part 1: Pertuzumab + Paclitaxel
Arm Type
Experimental
Arm Description
Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
Arm Title
Part 2: Pertuzumab+Chemotherapy
Arm Type
Experimental
Arm Description
Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
Arm Title
Part 2: Placebo+Chemotherapy
Arm Type
Placebo Comparator
Arm Description
Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine (Chemotherapy)
Intervention Description
Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel (Chemotherapy)
Intervention Description
Participants administered paclitaxel at a dosage of 80 mg/m^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Intervention Description
Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle.
Intervention Type
Drug
Intervention Name(s)
Topotecan (Chemotherapy)
Intervention Description
Participants administered topotecan at a dosage of 1.25 mg/m^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.
Primary Outcome Measure Information:
Title
Part 1: Percentage of Participants With Adverse Events (AEs)
Description
An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)
Title
Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)
Description
PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.
Time Frame
Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)
Secondary Outcome Measure Information:
Title
Part 1- Objective Response Rate (ORR)
Description
ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression)
Title
Part 2- Objective Response Rate (ORR)
Description
ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)
Title
Part 1: PFS Assessed by the Investigator
Description
PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day.
Time Frame
Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)
Title
Part 2: Progression-free Survival (PFS) Assessed by the Investigator
Description
PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.
Time Frame
Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)
Title
Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score
Description
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life.
Time Frame
Baseline (assessed at baseline and every 9 weeks from randomization until disease progression)
Title
Part 2: Percentage of Participants With Adverse Events (AEs)
Description
An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)
Title
Part 2: Overall Survival
Description
Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause
Time Frame
Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, and/or fallopian tube cancer that is platinum-resistant or refractory Low Human epidermal growth factor receptor (HER) 3 messenger ribonucleic acid (mRNA) expression At least one measurable and/or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.1 Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%) Negative serum pregnancy test in women of childbearing potential Women of childbearing potential must agree to use effective contraception as defined by protocol during and for at least 6 months post study treatment Exclusion Criteria: Non-epithelial tumors Ovarian tumors with low malignant potential (borderline tumors) History of other malignancy of prognostic relevance within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma, or tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the breast Previous treatment with more than 2 chemotherapy regimens Any prior radiotherapy to the pelvis or abdomen History or evidence on physical/neurological examination of central nervous system disease unrelated to cancer (uncontrolled seizures), unless adequately treated with standard medical therapy Pre-existing peripheral neuropathy >/= common toxicity criteria (CTC) grade 2 (applicable for paclitaxel cohort only) Inadequate organ function Uncontrolled hypertension or clinically significant cardiovascular disease Current known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV) Current chronic daily treatment with corticosteroids (>/= 10 mg per day of methylprednisolone or equivalent), excluding inhaled steroids History of receiving any investigational treatment within 28 days prior to first study drug administration For Part 2 of the trial: prior enrollment into Part 1 of the trial Concurrent participation in any therapeutic clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Herlev Hospital; Onkologisk afdeling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Rigshospitalet, Onkologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Francois Baclesse; Oncologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges Francois Leclerc; Oncologie 3
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CRLCC Val dAurelle Paul Lam
City
Montpellier cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Tenon; Oncologie Radiotherapie
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Clinique Armoricaine Radiologie; Hopital de Jour
City
Plerin
ZIP/Postal Code
22190
Country
France
Facility Name
Ico Rene Gauducheau; Oncologie
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Alexis Vautrin; Oncologie Medicale
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy; Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Evangelischen Krankenhauses Düsseldorf; Frauenklinik
City
Düsseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitätsklinikum Freiburg; Frauenklinik
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
City
Hannover
ZIP/Postal Code
30177
Country
Germany
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
UNI-Klinikum Campus Kiel Klinik f.Gynäkologie u.Geburtshilfe
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Klinikum Konstanz, Frauenklinik
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Universitätsklinik Tübingen; Frauenklinik
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm Am Michelsberg; Frauenklinik
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Regina Elena; Oncologia Medica A
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
City
Genova
State/Province
Liguria
ZIP/Postal Code
16128
Country
Italy
Facility Name
A.O.Spedali Civili; Ostetricia e Ginecologia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
A.O.U Pisana; Dipartimento di Ginecologia Oncologica
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
Antoni van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Academ Ziekenhuis Groningen; Medical Oncology
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Academisch Ziekenhuis Leiden; Clinical Oncology
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
UMC St Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
The Norvegian Radium Hospital Montebello; Dept of Oncology
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Son Llatzer; Servicio de Oncologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Duran i Reynals; Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Universitetssjukhuset; Onkologkliniken
City
Linkoeping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Skånes University Hospital, Skånes Department of Onclology
City
Lund
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31420414
Citation
Lorusso D, Hilpert F, Gonzalez Martin A, Rau J, Ottevanger P, Greimel E, Luck HJ, Selle F, Colombo N, Kroep JR, Mirza MR, Berger R, Pardo B, Grischke EM, Berton-Rigaud D, Martinez-Garcia J, Vergote I, Redondo A, Cardona A, Bastiere-Truchot L, du Bois A, Kurzeder C; PENELOPE trial investigators. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2019 Sep;29(7):1141-1147. doi: 10.1136/ijgc-2019-000370. Epub 2019 Aug 15.
Results Reference
derived

Learn more about this trial

Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

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