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An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Epithelial Ovarian Cancer

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Trial Information

An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CA125

Outcome Time Frame:

Every 3 weeks

Safety Issue:

No

Principal Investigator

Susan Weil, MD

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-003-002A

NCT ID:

NCT01018563

Start Date:

November 2009

Completion Date:

December 2013

Related Keywords:

  • Epithelial Ovarian Cancer
  • Extension study
  • Epithelial ovarian cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Sharp Memorial HospitalSan Diego, California  92123
South Texas Oncology & HematologySan Antonio, Texas  78207