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Trial record 1 of 1 for:    NCT01018563
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An Open Label Extension Study of the Efficacy of MORAb-003

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01018563
First received: November 18, 2009
Last updated: August 28, 2013
Last verified: August 2013

November 18, 2009
August 28, 2013
November 2009
March 2013   (final data collection date for primary outcome measure)
CA125 [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018563 on ClinicalTrials.gov Archive Site
Overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Every 18 weeks ] [ Designated as safety issue: No ]
Evaluation of tumor response by CT or MRI scans every 18 weeks as long as patient's condition is stable; every 9 weeks during chemotherapy, if indicated.
Overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Open Label Extension Study of the Efficacy of MORAb-003
An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epithelial Ovarian Cancer
Drug: MORAb-003
Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.
Other Name: Farletuzumab
Experimental: MORAb-003
Maintenance infusions of MORAb-003 every 3 weeks
Intervention: Drug: MORAb-003
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
August 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of Informed consent
  • Subjects must have been enrolled in and have met the inclusion/exclusion criteria of the MORAb-003-002 study.
  • Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or stable disease and an investigator's assessment of a clinical benefit) after MORAb-003 in combination with standard chemotherapy and have not yet met the criteria for disease progression during participation in the MORAb-003-002 study.
  • Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.

Exclusion Criteria:

  • Subjects that discontinued the MORAb-003-002 study for any reason.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01018563
MORAb-003-002A
No
Morphotek
Morphotek
Not Provided
Study Director: Susan Weil, MD Morphotek
Morphotek
August 2013

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