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

Morphotek

Status and phase: Terminated; Phase 2

Conditions: Epithelial Ovarian Cancer

Treatments: Drug: MORAb-003

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018563

2009-015825-36 (EudraCT Number)

MORAb-003-002A

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

MORAb-003

Experimental group

Description:

Maintenance infusions of MORAb-003 every 3 weeks

Treatment:

Drug: MORAb-003