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

Tracking Information

First Received Date ^ICMJE

November 18, 2009

Last Updated Date

January 8, 2013

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CA125 [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01018563 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Epithelial Ovarian Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: MORAb-003

Maintenance infusions of MORAb-003 every 3 weeks

Intervention: Drug: MORAb-003

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany

Administrative Information

NCT Number ^ICMJE

NCT01018563

Other Study ID Numbers ^ICMJE

MORAb-003-002A

Has Data Monitoring Committee

Responsible Party

Morphotek

Study Sponsor ^ICMJE

Morphotek

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Susan Weil, MD

Morphotek

Information Provided By

Morphotek

Verification Date

August 2011

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

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