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


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateSeptember 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 20, 2009)
Progression-free survival using by RECIST [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00849667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 20, 2009)
Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudy. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEEfficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Official Title  ICMJEA Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEOvarian Cancer
Intervention  ICMJE
  • Drug: MORAb-003 (farletuzumab)
    MORAb-003 1.25 mg/kg infusions will take place weekly, i.e. on Day1 and week1 of each 21-day cycle.
  • Drug: MORAb-003 (farletuzumab)
    MORAb-003 2.5mg/kg infusions will take place weekly, i.e. on Day1 and week1 of each 21-day cycle.
  • Drug: 0.9% Saline
    0.9% infusions will take place weekly, i.e. on Day1 and week1 of each 21-day cycle
Study Arms / Comparison Groups
  • 1: Active Comparator
    Carboplatin and taxane with MORAb-003 1.25 mg/kg
    Intervention: Drug: MORAb-003 (farletuzumab)
  • 2: Active Comparator
    Carboplatin and taxane with MORAb-003 2.5 mg/kg
    Intervention: Drug: MORAb-003 (farletuzumab)
  • 3: Placebo Comparator
    Carboplatin and taxane with Placebo
    Intervention: Drug: 0.9% Saline

Recruitment Information

Estimated Enrollment  ICMJE900
Completion Date 
Estimated Primary Completion DateSeptember 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 within ≥6 and < 24 months of completion of first-line platinum/taxane chemotherapy
  • Must be a candidate for repeat carboplatin/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
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Susan C Weil, MD, FACP610-423-6182weil@morphotek.com
Location Countries  ICMJEUnited States,   Australia,   Belgium,   Canada,   Chile,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00849667
Responsible PartySusan Weil, M.D. /Study Medical Monitor, Morphotek, Inc
Study ID Numbers  ICMJEMORAb003-004
Study Sponsor  ICMJEMorphotek
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByMorphotek