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

Phase 1

Completed

• Conditions: Carcinoma; Ovarian Cancer; Ovarian Diseases; Ovarian Neoplasms
• Interventions: Biological: AGS-8M4

• Registration Number: NCT00816764
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-01
• Study First Submitted QC: 2009-01-02
• Study First Posted: 2009-01-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-11
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1. AGS-8M4 Dose 1	AGS-8M4	-
2. AGS-8M4 Dose 2	AGS-8M4	-
3. AGS-8M4 Dose 3	AGS-8M4	-
4. AGS-8M4 Dose 4	AGS-8M4	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Throughout the treatment
Assessment of PK variables	Weeks 1-3, week 5, week 7 week 11, every 2 weeks during extension period, 2 and 3 months after last dose

Secondary Outcome Measures

Name	Time	Method
Incidence of anti-AGS-8M4 antibody formation	Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose
Changes in tumor status per RECIST	Week 9, and every 8 weeks during the extended treatment period
Changes in CA-125 levels	Week 9, and every 8 weeks during the extended treatment period