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

Phase 1

Terminated

• Conditions: Carcinoma; Ovarian Cancer; Ovarian Diseases; Ovarian Neoplasms
• Interventions: Biological: AGS-8M4; Drug: Pegylated liposomal doxorubicin (PLD); Drug: gemcitabine; Drug: carboplatin

• Registration Number: NCT01016054
• Lead Sponsor: Astellas Pharma Inc

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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)

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A. PLD plus AGS-8M4	Pegylated liposomal doxorubicin (PLD)	Women with platinum resistent ovarian cancer
B. Carboplatin and gemcitabine plus AGS-8M4	AGS-8M4	Women with platinum sensitive ovarian cancer
A. PLD plus AGS-8M4	AGS-8M4	Women with platinum resistent ovarian cancer
B. Carboplatin and gemcitabine plus AGS-8M4	gemcitabine	Women with platinum sensitive ovarian cancer
B. Carboplatin and gemcitabine plus AGS-8M4	carboplatin	Women with platinum sensitive ovarian cancer

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Throughout the treatment

Secondary Outcome Measures

Name	Time	Method
Assessment of PK variables	Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Incidence of anti-AGS-8M4 antibody formation	Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Changes in tumor status per RECIST	Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.
Change in CA-125 levels	Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U.