Trial Search Results

Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Morphotek

Stanford Investigator(s):

Intervention(s):

  • Drug: MORAb-003 (farletuzumab)
  • Drug: MORAb-003 (farletuzumab)
  • Drug: 0.9% Saline

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - A histologically or cytologically confirmed diagnosis of non-mucinous epithelial
   ovarian cancer including primary peritoneal or fallopian tube malignancies

   - Must have measurable disease by CT or MRI scan

   - Must have relapsed radiologically with a randomization date within ≥6 and < 24 months
   of completion of first-line platinum chemotherapy

   - Have been treated with debulking surgery and first-line platinum and taxane based
   chemotherapy.

   - 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.

   - Must be a candidate for carboplatin and taxane therapy

   - Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Exclusion Criteria:

   - 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

   - Subjects who have received other therapy to treat their ovarian cancer since relapse

   - Known central nervous system (CNS) tumor involvement

   - Evidence of other active invasive malignancy requiring treatment in the past 5 years

   - Known allergic reaction to a prior monoclonal antibody therapy or have any documented
   HAHA

   - Previous treatment with MORAb-003 (farletuzumab)

   - Clinical contraindications to use of a taxane

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting