An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (FAR-122)

This study has been terminated.
(study did not meet pre-specified criteria for continuation following interim futility analysis)
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00738699
First received: August 18, 2008
Last updated: November 18, 2013
Last verified: November 2013

August 18, 2008
November 18, 2013
September 2008
December 2011   (final data collection date for primary outcome measure)
  • Progression-free survival (PFS) as determined by RECIST [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
    PFS as determined by RECIST
  • Overall Survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Progression-free survival using GCIG response criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00738699 on ClinicalTrials.gov Archive Site
  • Progression Free Survival based on Gynecologic Cancer InterGroup(GCIG) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
    PFS as assessed byt CGIG criteria
  • Overall Response Rate [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Serologic response rate [ Time Frame: Length of study ] [ Designated as safety issue: No ]
    Serologic response rate assessed by modified Rustin Criteria
  • Safety and tolerability [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
    Assessed by safety measurements such as review of Adverse events, Vital signs, Physical exams, Electrocardiograms, Clinical labrotory tests, Karnofsky's performance status.
overall response,overall survival and cardiac substudy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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

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)
    2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
  • Drug: 0.9% Saline
    2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
  • Active Comparator: 1
    Paclitaxel with MORAb-003(farletuzumab)
    Intervention: Drug: MORAb-003 (farletuzumab)
  • Placebo Comparator: 2
    Paclitaxel 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.
 
Terminated
417
October 2012
December 2011   (final data collection date for primary outcome measure)

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).
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Netherlands,   Spain
 
NCT00738699
MORAb003-003PR
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