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

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ClinicalTrials.gov Identifier: NCT00816764
Recruitment Status : Completed
First Posted : January 5, 2009
Last Update Posted : February 27, 2013
Sponsor:
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
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 : October 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Throughout the treatment ]
  2. 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 :
  1. 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 ]
  2. Changes in tumor status per RECIST [ Time Frame: Week 9, and every 8 weeks during the extended treatment period ]
  3. Changes in CA-125 levels [ Time Frame: Week 9, and every 8 weeks during the extended treatment period ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816764


Locations
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.
Investigators
Study Director: Use Central Contact Agensys, Inc.

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00816764     History of Changes
Other Study ID Numbers: 2008001
First Posted: January 5, 2009    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: November 2010

Keywords provided by Astellas Pharma Inc:
clinical trial, phase 1
carcinoma
pharmacokinetics
safety
ovarian

Additional relevant MeSH terms:
Ovarian Neoplasms
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders