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

NCT ID: NCT01016054

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-04-30

Brief Summary

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.

Detailed 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.

Conditions

Carcinoma; Ovarian Cancer; Ovarian Diseases; Ovarian Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A. PLD plus AGS-8M4

Women with platinum resistent ovarian cancer

Group Type: EXPERIMENTAL

AGS-8M4

Intervention Type: BIOLOGICAL

IV infusion

Pegylated liposomal doxorubicin (PLD)

Intervention Type: DRUG

IV infusion

B. Carboplatin and gemcitabine plus AGS-8M4

Women with platinum sensitive ovarian cancer

Group Type: EXPERIMENTAL

AGS-8M4

Intervention Type: BIOLOGICAL

IV infusion

gemcitabine

Intervention Type: DRUG

IV infusion

carboplatin

Intervention Type: DRUG

IV infusion

Interventions

AGS-8M4

IV infusion

Intervention Type: BIOLOGICAL

Pegylated liposomal doxorubicin (PLD)

IV infusion

Intervention Type: DRUG

gemcitabine

IV infusion

Intervention Type: DRUG

carboplatin

IV infusion

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Agensys, Inc.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Use Central Contact

Role: STUDY_DIRECTOR

Agensys, Inc.

Locations

Duarte, California, United States

Countries

United States

Other Identifiers

2009001

Identifier Type: -

Identifier Source: org_study_id