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

• Conditions: First relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies; MedDRA version: 9.1Level: LLTClassification code 10033160Term: Ovarian epithelial cancer recurrent

• Registration Number: EUCTR2008-005872-29-GR
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-22
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 900

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.Must have measurable disease by CT or MRI scan
5.Must have relapsed radiologically within =6 and = 24 months of completion of first-line platinum/taxane chemotherapy
6.Must be a candidate for repeat carboplatin/taxane therapy
7.Life expectancy of =6 months as estimated by the investigator
8.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
9.Karnofsky performance status (KPS) =70%
10.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< 1.5x ULN (CTCAE Grade 1)
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase< 2.5 x ULN (CTCAE Grade 1)

11.Neurologic function: neuropathy (sensory and motor) =CTCAE Grade 1
12.Subject must provide written informed consent and be able to comply with the protocol procedures
(*=to the power)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified