Clinical trial · Interventional
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab) in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study did not meet pre-specified criteria for continuation following interim futility analysis
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% Saline | Drug | — | UNRESOLVED |
| MORAb-003 (farletuzumab) | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- MORAb-003 (Farletuzumab) Plus Paclitaxel
- interventionNames
- Drug: MORAb-003 (farletuzumab)
- Drug: Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo Plus Paclitaxel
- interventionNames
- Drug: 0.9% Saline
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available