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

This study has been completed.
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: January 1, 2009
Last updated: February 26, 2013
Last verified: November 2010
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 Intervention Phase
Ovarian Cancer
Ovarian Diseases
Ovarian Neoplasms
Biological: AGS-8M4
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Throughout the treatment ]
  • Assessment of PK variables [ Time Frame: 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 [ Time Frame: Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose ]
  • Changes in tumor status per RECIST [ Time Frame: Week 9, and every 8 weeks during the extended treatment period ]
  • Changes in CA-125 levels [ Time Frame: Week 9, and every 8 weeks during the extended treatment period ]

Enrollment: 18
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00816764

United States, Maryland
Baltimore, Maryland, United States, 19111
United States, New York
New York, New York, United States, 10021
New York, New York, United States, 10032
Sponsors and Collaborators
Astellas Pharma Inc
Agensys, Inc.
Study Director: Use Central Contact Agensys, Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00816764     History of Changes
Other Study ID Numbers: 2008001
Study First Received: January 1, 2009
Last Updated: February 26, 2013

Keywords provided by Astellas Pharma Inc:
clinical trial, phase 1

Additional relevant MeSH terms:
Ovarian Neoplasms
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders processed this record on May 25, 2017