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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00849667
First received: February 13, 2009
Last updated: November 18, 2013
Last verified: November 2013

February 13, 2009
November 18, 2013
April 2009
December 2012   (final data collection date for primary outcome measure)
Progression-free survival using by RECIST [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00849667 on ClinicalTrials.gov Archive Site
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: 3 years ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
A 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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: MORAb-003 (farletuzumab)
    MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
  • Drug: MORAb-003 (farletuzumab)
    MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
  • Drug: 0.9% Saline
    0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
  • Active Comparator: 1
    Carboplatin and taxane with MORAb-003 1.25 mg/kg
    Intervention: Drug: MORAb-003 (farletuzumab)
  • Active Comparator: 2
    Carboplatin and taxane with MORAb-003 2.5 mg/kg
    Intervention: Drug: MORAb-003 (farletuzumab)
  • Placebo Comparator: 3
    Carboplatin and taxane with Placebo
    Intervention: Drug: 0.9% Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
April 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom
 
NCT00849667
MORAb003-004
Yes
Morphotek
Morphotek
Not Provided
Not Provided
Morphotek
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP