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

Ovarian Cancer Clinical Trial

Official title:

A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01016054
• Other study ID #: 2009001
• Status: Terminated
• Phase: Phase 1
• First received: November 16, 2009
• Last updated: February 26, 2013
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Cancer
• Ovarian Diseases
• Ovarian Neoplasms

Intervention

Biological:
• AGS-8M4
IV infusion

Drug:
• Pegylated liposomal doxorubicin (PLD)
IV infusion
• gemcitabine
IV infusion
• carboplatin
IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Agensys, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Throughout the treatment	No
Secondary	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.	No
Secondary	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.	No
Secondary	Changes in tumor status per RECIST		Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.	No
Secondary	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.	No

External Links

•   Link to results on JAPIC