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A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer


Title A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer
Therapeutic Area Ovarian Cancer
Principal Investigator Young B. Kim, MD
Min Age 18 Years
Gender Both
Contact Amy Quinkert
617-636-8589
More Information https://clinicaltrials.gov/ct2/show/NCT02289950

Overview

This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.

Study Details

Inclusion Criteria

  • Subjects with ovarian cancer at first relapse with low CA125 and visible disease.
  • Relapse occurred between 6 months and 3 years of original platinum chemotherapy
  • Otherwise normal organ function

Exclusion Criteria

  • No other complicating malignancies such as heart disease active or an active infection
  • No known allergic reaction to monoclonal antibody therapies or previous treatment with Farletuzamab or cancer vaccine therapy
  • No pregnant or nursing women

Study Requirements

This study includes 30 days of screening, 15 months receiving study drug, and an estimated follow up period of 30 months. Study drug will be given once a week, every week. CT or MRI scans will occur every 6 weeks while receiving study drug in combination with Chemotherapy and every 9 weeks when receiving study drug alone.