Text Size

An Open Label Extension Study of the Efficacy of MORAb-003

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01018563
First received: November 18, 2009
Last updated: January 8, 2013
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
 Drug: MORAb-003
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Morphotek:

Primary Outcome Measures:
  • CA125 [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 3
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MORAb-003
Maintenance infusions of MORAb-003 every 3 weeks
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018563

Locations
United States, California
Sharp Memorial Hospital
Chula Vista, California, United States, 91911
United States, Texas
South Texas Oncology & Hematology
San Antonio, Texas, United States, 78229
Germany
Nationales Centrum fur Tumorerkrandungen
Heidelberg, Germany, 69120
Sponsors and Collaborators
Morphotek
Investigators
Study Director: Susan Weil, MD Morphotek
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01018563     History of Changes
Other Study ID Numbers: MORAb-003-002A
Study First Received: November 18, 2009
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
Extension study
Epithelial ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013