First relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies MedDRA version: 14.0 Level: PT Classification code 10033160 Term: Ovarian epithelial cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Female subjects =18 years of age 2.Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. Contraceptive measures must start either prior to or at screening and continue throughout the entire study period and for 2 months after the last dose of study drug is administered. Pregnant and/or lactating females are excluded 3.A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies 4.Have been treated with debulking surgery and first–line platinum and taxane based chemotherapy 5.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. 6.Must have measurable disease by CT or MRI scan 7.Must have relapsed radiologically with a randomization date within =6 and = 24 months of completion of first-line platinum/taxane chemotherapy 8.Must be a candidate for repeat carboplatin and taxane therapy 9.Life expectancy of =6 months as estimated by the investigator 10.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1 11.Karnofsky performance status (KPS) =70% 12.Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows: Absolute neutrophil count (ANC) = 1.5 x 10*9/L Platelet count = 100 x 10*9/L Hemoglobin = 9 g/dL Creatinine =1.5x ULN (CTCAE Grade 1) Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 720
Exclusion criteria
Exclusion criteria: 1.Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs 24 months from the last platinum therapy 2.Subjects who have received other therapy to treat their ovarian cancer since relapse 3.Known central nervous system (CNS) tumor involvement 4.Evidence of other active invasive malignancy requiring treatment in the past 5 years 5.Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months) 6.Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible) 7.Active serious systemic disease, including active bacterial or fungal infection 8.Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary. 9.Other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed) 10.Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA 11.Previous treatment with MORAb-003 (farletuzumab) 12.Clinical contraindications to use of a taxane 13.Prior treatment with any investigational agent within 4 weeks of study entry 14.Breast-feeding, pregnant, or likely to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of two dose levels of MORAb-003 or placebo in combination with carboplatin and taxane on progression-free survival (PFS), as determined by RECIST, in subjects with platinum-sensitive ovarian cancer in first relapse. ;Secondary Objective: •To assess the effect of MORAb-003 on overall survival (OS) •To assess the effect of MORAb-003 on CA-125 defined PFS and serologic response, based on Rustin criteria •To assess the effect of MORAb-003 to prolong second remission longer than first remission •To assess the effect of MORAb-003 on best objective response (OR) rate, time to response (TTR) and duration of response (DR) by RECIST criteria •To compare the serologic response of low- (1.25 mg/kg) and high- (2.5 mg/kg) dose MORAb-003 to each other in combination with carboplatin and taxane, and to placebo plus carboplatin and taxane •To assess the safety and tolerability of both dose levels of MORAb-003 •To assess the effect of MORAb-003 on subject-reported on Quality of Life (QoL) •To assess the effect of MORAb-003 on resource utilization;Primary end point(s): Progression-free survival (PFS) is the primary efficacy endpoint, defined as the time from randomization to progression by RECIST (as measured using independent review of CT/MRI scans as outlined in the Central Radiology Charter and Statistical Analysis Plan), or death from all causes. ;Timepoint(s) of evaluation of this end point: PFS is 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 (RECIST), or date of death, whatever the cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: OS is defined as the time from the date of randomization to the date of death, due to all causes. If death is not observed for a subject, the survival time will be censored on the last date known to be alive or the cut-off date, whichever is earliest. CA-125 PFS is 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. GCIG PFS is defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the GCIG criteria, or date of death, whatever the cause.;Secondary end point(s): Overall Survival (OS); CA-125 PFS (Rustin Criteria); GCIG PFS (GCIG Criteria); Tumor Response (OR, TTR, DR per RECIST); Serologic Response (CA-125); length of first versus second remission; Subject-reported Quality of Life (QoL); and Resource utilization [hospitalizations (inpatient or outpatient, length of stay), unscheduled office visits, and admission to hospice or nursing home] | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Poland, Portugal, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactMedical Information
Eisai Limited
Outcome results
None listed