A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer

NCT ID: NCT00816764

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-06-30

Brief Summary

This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.

Detailed Description

All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled sequentially into 1 of the 4 planned dose cohorts according to a standard dose escalation study design. A disease assessment will be performed at study week 9 (+/- 3 days). The assessment will be based on clinical signs and symptoms, changes in radiographic images, and changes in CA-125 levels. Subjects without evidence of disease progression may continue to receive AGS-8M4 during the extended treatment period at the dose and schedule of their assigned cohort until disease progression intolerability of AGS-8M4 or consent withdrawal. For subjects that continue dosing, disease assessments will be performed every 8 weeks during the extended treatment period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-8M4.

Conditions

Carcinoma; Ovarian Cancer; Ovarian Diseases; Ovarian Neoplasms

Study Design

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

Study Groups

1. AGS-8M4 Dose 1

Group Type: EXPERIMENTAL

AGS-8M4

Intervention Type: BIOLOGICAL

IV Infusion

2. AGS-8M4 Dose 2

Group Type: EXPERIMENTAL

AGS-8M4

Intervention Type: BIOLOGICAL

IV Infusion

3. AGS-8M4 Dose 3

Group Type: EXPERIMENTAL

AGS-8M4

Intervention Type: BIOLOGICAL

IV Infusion

4. AGS-8M4 Dose 4

Group Type: EXPERIMENTAL

AGS-8M4

Intervention Type: BIOLOGICAL

IV Infusion

Interventions

AGS-8M4

IV Infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
• Subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or nonmeasureable disease after first line therapy) or progressive disease at anytime

Exclusion Criteria

• No epithelial ovarian tumors of low malignant potential
• Active infection requiring treatment with systemic anti-infectives within 72 hours of screening
• Use of any investigational drug within 30 days prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
• Prior monoclonal antibody therapy

• 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

Baltimore, Maryland, United States

New York, New York, United States

New York, New York, United States

Countries

United States

Other Identifiers

2008001

Identifier Type: -

Identifier Source: org_study_id