Platinum-Resistant or Refractory Relapsed Ovarian Cancer MedDRA version: 9.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Interventions
Product Name: farletuzumab
Product Code: MORAb-003
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: farletuzumab
CAS Number: 896723-44-7
Current Sponsor code: MORAb-003
Concentration uni
Sponsors
Morphotek, Inc
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 diagnosis of non-mucinous epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube malignancies. Must have measurable disease by CT or MRI scan, or progression defined by CA-125 per the modified GCIG criteria (Section 3.1, Table 1), assessed within 4 weeks prior to study entry. 4. Must have been treated with surgery for ovarian cancer and received at least one line of platinum-based chemotherapy. 5. At least one of the lines of platinum containing chemotherapy must have included a taxane. 6. Must have relapsed during or within 6 months of platinum-containing chemotherapy. 7. Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance. 8. Subjects must be a candidate for repeat weekly paclitaxel. 9. Life expectancy of =3 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. Subjects must not be receiving total parenteral nutrition (TPN) 13. Laboratory test results within the 30 days prior to Study Day 1 as follows: ANC count > 1.5x109/L Platelet count > 100x9/L Hemoglobin > 8g/dL Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known central nervous system (CNS) tumor involvement. 2. Clinical contraindications to use of paclitaxel. 3. Evidence of active invasive malignancy other than ovarian cancer requiring treatment in the past 5 years. 4. Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did not receive prior chemotherapy for any ovarian tumor. 5. Clinically significant heart disease (e.g., congestive heart failure or New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months). 6. 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 symptomatic human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary. 9. Breast-feeding, pregnant, or likely to become pregnant during the study. 10. Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal. 11. Other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception of low-dose corticosteroids). 12. Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA). 13. Previous treatment with MORAb-003 (farletuzumab). 14. Prior treatment with any investigational agent within 4 weeks of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of weekly paclitaxel plus MORAb-003 to weekly paclitaxel plus placebo on progression-free survival (PFS) in subjects with relapsed platinum-resistant or refractory ovarian cancer;Secondary Objective: To compare the effects of the 2 treatment arms on the following: •Overall response rate (ORR) •Overall survival (OS) •To assess the safety and tolerability of MORAb-003 in combination with weekly paclitaxel •Changes in CA-125 levels per Gynecologic Cancer Inter Group (GCIG) criteria •To determine, via a cardiac sub-study, the effect of MORAb-003 cardiac repolarization as defined by the QTcF interval ;Primary end point(s): Efficacy: Primary: • PFS based on GCIG criteria, according to both Response Evaluation Criteria in Solid Tumors (RECIST) or CA 125 values Secondary: • Overall response rate (based on RECIST or CA-125) • Overall survival • Serologic Response (based on Rustin criteria) Safety: • Adverse events (including drug hypersensitivity reactions) • Clinical laboratory tests (serum chemistry, hematology, urinalysis) • Tolerability (discontinuations, treatment delays, dose reductions) • Physical examinations (including vital signs assessment) • Cardiac safety sub-study with a particular emphasis on QTcF interval • Standard ECG assessments Standard adverse event (AE) monitoring and grading will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0, and coded using Medical Dictionary for Regulatory Activities (MedDRA). | — |
Countries
Belgium, Netherlands, Spain
Outcome results
None listed