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An Efficacy and Safety Study of MORAb-003 in First Platinum-Resistant or Refractory Relapsed Ovarian Cancer
This study is currently recruiting participants.
Study NCT00738699   Information provided by Morphotek
First Received: August 18, 2008   Last Updated: May 4, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

August 18, 2008
May 4, 2009
September 2008
Progression-free survival using GCIG response criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738699 on ClinicalTrials.gov Archive Site
overall response,overall survival and cardiac substudy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
 
An Efficacy and Safety Study of MORAb-003 in First 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 First Platinum-Resistant or Refractory Relapsed Ovarian Cancer

This research is being done to find out if paclitaxel works better when given together with an experimental drug called MORAb-003(farletuzumab) or alone in patients with first platinum-resistant or refractory relapsed ovarian cancer

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Ovarian Cancer
  • Drug: MORAb-003 (farletuzumab)
  • Drug: 0.9% Saline
  • Active Comparator: Paclitaxel with MORAb-003(farletuzumab)
  • Placebo Comparator: Paclitaxel with Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
126
November 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of non-mucinous epithelial ovarian cancer measurable by CT or MRI scan, or progression defined by radiologic criteria or by biomarker (CA-125 ≥ 1.5 x ULN) assessed within 4 weeks prior to study entry
  • Must have relapsed within 6 months of first or second line platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
  • Must have been initially treated with surgery NS first or second line platinum-based chemotherapy;
  • 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: Debasis Chakrabarti, MD, PhD 610-423-6176 dchakrabarti@morphotek.com
United States,   Australia,   Canada
 
 
NCT00738699
Debasis Chakrabarti, M.D., PhD/ Study Director, Morphotek, Inc
 
Morphotek
 
 
Morphotek
December 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.