A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer

Astellas

Status and phase: Terminated; Phase 1

Conditions: Ovarian Neoplasms; Carcinoma; Ovarian Cancer; Ovarian Diseases

Treatments: Drug: Pegylated liposomal doxorubicin (PLD); Drug: carboplatin; Biological: AGS-8M4; Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01016054

2009001

Details and patient eligibility

About

This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.

Full description

All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
• Subjects with either platinum resistant or platinum sensitive ovarian cancer
• At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
• Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)

Exclusion criteria

• Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
• Use of any investigational drug within 30 days prior to screening
• Prior monoclonal antibody therapy other than Avastin
• Avastin administration within 90 days of screening
• History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

A. PLD plus AGS-8M4

Experimental group

Description:

Women with platinum resistent ovarian cancer

Treatment:

Drug: Pegylated liposomal doxorubicin (PLD)

Biological: AGS-8M4

B. Carboplatin and gemcitabine plus AGS-8M4

Experimental group

Description:

Women with platinum sensitive ovarian cancer

Treatment:

Drug: carboplatin

Biological: AGS-8M4

Drug: gemcitabine