An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (FAR-122)

Morphotek

Status and phase

Terminated

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: 0.9% Saline

Drug: MORAb-003 (farletuzumab)

Drug: Paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00738699

MORAb003-003PR

Details and patient eligibility

About

The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer

Full description

Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.

Enrollment

415 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks prior to study entry
Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically within 6 months of most recent platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
Must have been treated with debulking surgery and at least one line platinum-based chemotherapy;
Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.
Subjects must be candidate for repeat paclitaxel treatment

Exclusion criteria

Clinical contraindications to use of paclitaxel, which include:
1. persistent Grade 2 or greater peripheral neuropathy
2. prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation
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
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
Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).
Previous treatment with MORAb-003 (farletuzumab).