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

• Conditions: Platinum-sensitive epithelial ovarian cancer

• Registration Number: EUCTR2009-015825-36-DE
• Lead Sponsor: Morphotek, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-19
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

1. Provision of informed consent

2. Subjects must currently be enrolled in and have met the inclusion/exclusion criteria of the MORAb-003-002 study

3. 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 criteria for disease progression and during participation on MORAb-003-002 study

4. Subjects must be currently receiving single-agent MORAb-003 maintenance therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects that discontinued the MORAb-003-002 study for any reason

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified