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Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

Primary Purpose

Ovarian Cancer

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Farletuzumab

Carboplatin

Taxane

Farletuzumab-matched placebo

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, relapsed ovarian cancer, Platinum-sensitive Ovarian Cancer

Eligibility Criteria

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

Inclusion Criteria:

A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
Must have measurable disease by CT or MRI scan
Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy
Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
Must be a candidate for carboplatin and taxane therapy
Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Exclusion Criteria:

Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
Subjects who have received other therapy to treat their ovarian cancer since relapse
Known central nervous system (CNS) tumor involvement
Evidence of other active invasive malignancy requiring treatment in the past 5 years
Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
Previous treatment with MORAb-003 (farletuzumab)
Clinical contraindications to use of a taxane

Sites / Locations

University Of Alabama At Birmingham
Oncology Specialties, PC
Arizona Hematology & Oncology Associates
St. Joseph's Hospital, Barrow Neurology Clinics
Arizona Oncology Associates
Arizona Cancer Center
Providence St. Joseph Medical Center
California Cancer Care, Inc.
University of California San Diego
University of California Los Angeles Medical Center
Gynecologic Oncology Associates
University of California Davis Cancer Center
Stanford University
University of Colorado
Catholic Health Initiatives
Denver Health and Hospital Authority
Hematology Oncology P.C.
Washington Hospital Center
Palm Beach Institute of Hematology and Oncology
University Cancer Institute
Gainsville Hematology Oncology Associates
Baptist Cancer Institute
Jupiter Medical center Physician's Group
Hematology/Oncology Associates
Lakeland Regional Cancer Center
Florida Hospital
Gulfcoast Oncology
Sarasota Memorial Healthcare System
Oncology-Hematology Associates of W. Broward P.A.
Palm Beach Cancer Institute
Medical College of Georgia
Memorial Health University Medical Center
Kaiser Permanente - Moanalua Medical Center
Kapi'olani Medical Center for Women and Children
Medical & Surgical Specialists, LLC
Ingalls Memorial Hospital
Loyola University Chicago
Midwest Cancer Research Group
Central DuPage Hospital
St. Francis Hospital & Health Centers
St. Vincent Gynecologic Oncology
Central Baptist Hospital
University of Louisville
Norton Healthcare
Hematology & Oncology Specialists
Mercy Medical Center
Greater Baltimore Medical Center
John Hopkins University
Weinberg Cancer Institute at Franklin Square
Center for Cancer and Blood Disorders
Frederick Memorial Hospital
Barbara Ann Kamanos Cancer Center
Henry Ford Health System
Saint Mary's Health Care
Sparrow Regional Cancer Center
Park Nicollet Institute
Saint Francis Memorial Health Center
Good Samaritan Hospital Cancer Center
The Center for Cancer and Hematologic Disease
Hematology-Oncolgy Associates of NNJ-PA
John Theurer Cancer Center at Hackensack University MC
Morristown Memorial Hospital
Cooper Cancer Institute
University of New Mexico Cancer Center
Roswell Park Cancer Institute
Arena Oncology Associates
Columbia University Medical Center
SUNY Upstate Medical University
Carolinas Medical Center
Presbyterian Hospital
Duke University Medical Center
Piedmont Hematology & Oncology
Catholic Health Initiatives
University Hospitals of Cleveland
MetroHealth Medical Center
Miami Valley Hospital
Kettering Medical Center
Signal Point Clinical Research Center, LLC
Cancer Care Associates
Providence Oncology & Hematology Care
Kaiser Permanente Northwest
Oregon Health & Science University
Willamette Valley Cancer Center
Abington Memorial Hospital
St. Luke's Hospital
Oncology Hematology Associates
Gettysburg Cancer Center
Magee-Womens Hospital of UPMC
Western Pennsylvania Hospital
Medical University of South Carolina
Chattanooga's Program in Women's Oncology
Vanderbilt University Medical Center
Texas Oncology, PA
Texas Oncology, P.A.
Texas Oncology, PA
Baylor Sammons Cancer Center
International Beneficence Clinical Research, L.L.C.
University of Texas Health Science Center at Houston Medical School
South Texas Oncology and Hematology, PA
Scott and White Memorial Hospital
US Oncology Research
Northern Utah Associates
Utah Cancer Specialists
Northern Virginia Pelvic Surgery Associates
Peninsula Cancer Institute - Riverside Gynecology Oncology
Harrison Bremerton Hematology and Oncology
Providence Everett Medical Center
Cancer Care Northwest-South
Northwest Cancer Specialists, PC
Aurora Health Care
Hospital Zonal Especializado en Oncología de Lanús
Consultorios Medicos Privados SA
Fundación Sanatorio Güemes
Clinica Universitaria Reina Fabiola
Instituto Medico Platense
Centro Oncologico Riojano Integral (CORI)
Hospital Bocalandro
Centro Oncologico Integral
CER Instituto Medico
Centro Médico San Roque
Centro Medico de Alta Complejidad Cemac
ISIS Centro Especializado de LUCE SA
Tweed Hospital
Westmead Hospital
The Royal Brisbane and Women's Hospital
Mater Adult Hospital
North Adelaide Oncology Clinical Trials
Sir Charles Gairdner Hospital
Landeskrankenhaus Villach
Kaiser-Franz-Josef Spital
Krankenhaus Wien-Hietzing
Institut Jules Bordet
Cliniques Universitaires Saint-Luc
UZ Gent
AZ Groeninge - Campus Maria's Voorzienigheid
UZ Leuven
CHU de Liège
Sint-Augustinuskliniek
Fundação Pio XII - Hospital de Câncer de Barretos
Instituto de Pesquisas Clínicas para Estudos Multicêntricos
Santa Casa da Misericórdia de Curitiba
Instituto do Câncer do Ceará - ICC
Hosp. Araujo Jorge
Associação Hospital de Caridade Ijuí
Clinica de Neoplasias Litoral
Hospital Amaral Carvalho
Liga Norte-Riograndense Contra o Câncer
Irmandade Santa Casa de Misericórdia de Porto Alegre
Clínica de Oncologia de Porto Alegre S/S Ltda
Instituto Ribeirãopretano de Combate ao Câncer
INCA - Instituto Nacional do Câncer
Clínica Oncologistas Associados
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
Clínica AMO - Assistência Multidiciplinar em Oncologia
Centro de Estudos de Oncologia da FMABC
Saúde ABC Serviços Médicos Hospitalares Ltda
Instituto do Câncer Arnaldo Vieira de Carvalho
Certo Oncologia
Hospital Premier
Tom Baker Cancer Centre
Cancer Center For The Southern Interior
British Columbia Cancer Agency
BCCA
The Moncton Hospital
Ottawa Hospital
Instituto de Terapias Oncologicas
Instituto Clínico Oncológico del Sur
Instituto Oncologico Ltda.
Centre Régional de lutte contre le cancer Paul Papin
Centre Hospitalier Louis Pasteur
Institut Paoli Calmettes
Hôpital Saint Louis
Institut Jean Godinot - Centre de lutte contre le cancer
Helios Klinikum Berlin-Buch
Charité - Universitätsmedizin Berlin
Klinikum Chemnitz gGmbH
Marien-Hospital Akademisches Lehrkrankenhaus
Frauenarztpraxis Dr. med. Gröll de Rivera
Universitätsklinikum Essen
Krankenhaus Nordwest
Universitätsklinikum Freiburg
Kath. Marienkrankenhaus gGmbH
Universität Heidelberg
St. Vincentius Kliniken Karlsruhe
Universitätsklinik Magdeburg
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Klinikum der Universität München - Innenstadt
Rotkreuzklinikum München
Klinikum Südstadt Rostock
Klinikum Traunstein
University General Hospital of Heraklion
Alexandra Hospital
General Oncology Hospital Kifissias "Oi Agioi Anargyroi"
University General Hospital of Patras
Papageorgiou General Hospital
Queen Mary Hospital
Tuen Mun Hospital
Semmelweis Egyetem
Semmelweis Egyetem
Petz Aladár Megyei Oktató Kórház
Bács-Kiskun Megyei Önkormányzat Kórháza
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet
Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet
Apollo Hospitals International Limited
Kidwai Memorial Institute of Oncology
Jawaharlal Nehru Cancer Hospital & Research Centre
Jehangir, Clinical Development Centre
Ruby Hall Clinic
Dr. Kamakshi Memorial Hospital
Chittaranjan National Cancer Institute
M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board
Amrita Institute of Medical Sciences and Research Centre
MNJ Institute of Oncology and Regional Cancer Centre
SK Soni Hospital
Bhagwan Mahaveer Cancer Hospital and Research Centre
Lakeshore Hospital
Tata Memorial Hospital
Shatabdi Superspeciality Hospital
Curie Manavata Cancer Centre
All India Institute of Medical Sciences
Regional Cancer Centre
Rambam Medical Center
Linn Medical Center, Clalit Health Services
Wolfson Centre
Shaare Zedek Medical Center
Hadassah University Hospital Ein Kerem
Meir Medical Center
Rabin Medical Center
The Chaim Sheba Medical Center
Kaplan Medical Center
Assaf Harofe Medical Center
Centro di Riferimento Oncologico
Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Istituto Ospedaliero Fondazione Poliambulanza
Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche
Azienda Ospedaliera Cannizzaro
Humanitas Centro Catanese di Oncologia
Azienda Ospedaliera Sant'Anna
Ospedale di Faenza
Azienda Ospedaliera Universitaria San Martino
Presidio Ospedaliero Vito Fazzi
Ospedale Mater Salutis ULSS 21 della regione Veneto
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Fondazione Centro San Raffaele del Monte Tabor
Istituto Nazionale dei Tumori
Azienda Ospedaliera Niguarda Cà Granda
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"
Ospedale Sacro Cuore Don Calabria
Istituto Oncologico Veneto
Ospedale Santa Maria della Misericordia di Perugia
Ospedale Santa Maria delle Croci
Arcispedale Santa Maria Nuova
Azienda Policlinico Umberto I
Policlinico Universitario "A. Gemelli"
Azienda Ospedaliero-Universitaria di Udine
National Cancer Center
Gachon University Gil Medical Center
Cheil General Hospital & Women's Healthcare Center
Seoul national univercity hospital
Severance Hospital, Yonsei University College of Medicine
Samsung Medical Center
Asan Medical Center
Union Medica Quirurgica de Colima
Triva Investigaciones Medicas Sociedad Anónima de Capital Variable
Hospital Regional de Veracruz
VU Medisch Centrum
Albert Schweitzer Ziekenhuis
Academisch Ziekenhuis Maastricht
Orbis Medisch Centrum
Perpetual Succour Hospital
Cebu Gynecologic Cancer Care Clinic
Manila Doctors Hospital
San Juan de Dios Hospital
St. Luke's Medical Center
National Kidney and Transplant Institute
Bialostockie Centrum Onkologii
Wojewodzkie Centrum Onkologii
Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Centrum Onkologii Ziemi Lubelskiej
Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.
Wielkopolskie Centrum Onkologii
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie
Wojskowy Instytut Medyczny
Hospitais da Universidade de Coimbra
Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE
Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)
Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
Hospital de São João
Kursk Regional Oncology Centre
Russian Oncology Research Center named after N.N. Blokhin
Russian Oncology Research Center
Moscow Research Oncology Institute n.a. P.A.Gertsen
Medical Radiology Research Center of RAMS
Ryazan Regional Clinical Oncology Dispensary
City Clinical Oncology Dispensary
Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare
National University Hospital
National Cancer Centre
KK Women's and Children's Hospital
Hospital Universitario Reina Sofia
Hospital Virgen del Rocio
Hospital Son Llatzer
Hospital Universitario Vall D'Hebron
Hospital Clinic i Provincial
Hospital de Mataró
Corporació Sanitaria Parc Taulí
Hospital Mutua de Terrassa
Hospital General Universitario de Elche
Fundación Instituto Valenciano de Oncología
Fundacion Hospital Alcorcon
Hospital General Universitario Gregorio Marañon
Hospital Universitario Ramón y Cajal
Hospital 12 de Octubre
Hospital Clinico San Carlos
Universität Zürich
National Cheng Kung University Hosptial
National Taiwan University Hospital
Mackay Memorial Hospital
Taipei Veterans General Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital
Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"
Chernivtsi Regional Clinical Oncology Dispansery
Kiev City Oncology Hospital
Volyn Regional Oncology Dispensary
Belfast City Hospital
Velindre Hospital
University Hospital Coventry
Ninewells Hospital
Beatson Oncology Centre
Leicester Royal Infirmary
Royal Marsden Hospital
Hammersmith Hospital
Derriford Hospital
Poole Hospital NHS Trust
Weston Park Hospital
Clatterbridge Centre For Oncology
New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Farletuzumab (1.25 mg/kg)

Farletuzumab (2.5 mg/kg)

Placebo

Arm Description

Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel [175 milligram per meter square {mg/m^2}] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain area under curve [AUC] 5-6 milligram per milliliter per minute [mg/mL/minute]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.

Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.

Participants will receive farletuzumab-matched placebo (0.9 percent [%] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors [RECIST]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).

Secondary Outcome Measures

Overall Survival (OS)

OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.

Cancer Antigen-125 (CA-125) Progression-Free Survival

CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (>=) 2 multiple (*) ULN with either event documented on two occasions or CA-125 >=2*nadir value with either event documented on two occasions.

Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria

PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 >=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 >=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 >=two times ULN on two occasions at least one week apart.

Percentage of Participants With Length of Second Remission Greater Than First Remission

Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

Percentage of Participants With Objective Response

Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

Duration of Tumor Response

Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.

Time to Tumor Response (TTR)

Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.

Percentage of Participants With Serologic Response (SR)

SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.

Duration of 50% Serologic Response

Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

Time to 50% Serologic Response (TSR)

TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

Percentage of Participants With Clinical Benefit

Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.

Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel

AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel

T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel

CL: Clearance of Total Carboplatin and Total Paclitaxel

Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel

Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores

Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.

Full Information

NCT ID

NCT00849667

First Posted

February 13, 2009

Last Updated

December 5, 2022

Sponsor

Morphotek

Collaborators

Eisai Europe Ltd. (United Kingdom)

1. Study Identification

Unique Protocol Identification Number

NCT00849667

Brief Title

Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

Official Title

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy

Study Start Date

April 16, 2009 (Actual)

Primary Completion Date

December 31, 2012 (Actual)

Study Completion Date

April 12, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Morphotek

Collaborators

Eisai Europe Ltd. (United Kingdom)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

6. Conditions and Keywords

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

Ovarian Cancer

Keywords

ovarian cancer, relapsed ovarian cancer, Platinum-sensitive Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Farletuzumab (1.25 mg/kg)

Arm Type

Active Comparator

Arm Description

Arm Title

Farletuzumab (2.5 mg/kg)

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Farletuzumab

Other Intervention Name(s)

MORAb-003

Intervention Description

Farletuzumab IV infusion.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Carboplatin IV infusion.

Intervention Type

Drug

Intervention Name(s)

Taxane

Intervention Description

Taxane (Paclitaxel or Docetaxel) IV infusion.

Intervention Type

Drug

Intervention Name(s)

Farletuzumab-matched placebo

Intervention Description

Farletuzumab-matched placebo IV infusion.

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

Time Frame

From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)

Title

Cancer Antigen-125 (CA-125) Progression-Free Survival

Description

Time Frame

From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Title

Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria

Description

Time Frame

From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Title

Percentage of Participants With Length of Second Remission Greater Than First Remission

Description

Time Frame

From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)

Title

Percentage of Participants With Objective Response

Description

Time Frame

From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)

Title

Duration of Tumor Response

Description

Time Frame

From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)

Title

Time to Tumor Response (TTR)

Description

Time Frame

From the date of randomization to first documentation of objective response (up to 48 months)

Title

Percentage of Participants With Serologic Response (SR)

Description

Time Frame

Up to 48 months

Title

Duration of 50% Serologic Response

Description

Time Frame

From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)

Title

Time to 50% Serologic Response (TSR)

Description

Time Frame

From the date of randomization to first documentation of 50% SR (up to 48 months)

Title

Percentage of Participants With Clinical Benefit

Description

Time Frame

Up to 48 months

Title

Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel

Time Frame