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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Farletuzumab

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.