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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00816764

Collaborator

Agensys, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms	Biological: AGS-8M4	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-8M4 Given as Monotherapy in Subjects With Advanced Ovarian Cancer

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. AGS-8M4 Dose 1	Biological: AGS-8M4 IV Infusion
Experimental: 2. AGS-8M4 Dose 2	Biological: AGS-8M4 IV Infusion
Experimental: 3. AGS-8M4 Dose 3	Biological: AGS-8M4 IV Infusion
Experimental: 4. AGS-8M4 Dose 4	Biological: AGS-8M4 IV Infusion

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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