A Study of Chemotherapy Treatment for Patients With Ovarian Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: LY573636-sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00428610

H8K-MC-JZAG (Other Identifier)

10410

Details and patient eligibility

About

The primary objective is to determine whether LY573636-sodium (hereafter referred to as LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and CA-125 tests will be done before the first dose and then after every other treatment.

Enrollment: 103 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
• At least 18 years old
• Have received at least one but no more than 2 systemic treatment regimens containing platinum (does not include regimens received before surgery for this cancer)
• Have platinum-resistant disease

Exclusion criteria

• Have received more than 2 systemic treatment regimens for platinum-resistant disease
• Serious pre-existing medical conditions
• Actively receiving warfarin (Coumadin) for treatment of venous thrombosis or other prothrombotic conditions

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

LY573636

Experimental group

Description:

LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met.

Treatment:

Drug: LY573636-sodium