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

February 26, 2013 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 19111
    • New York
      • New York, New York, United States, 10032
      • New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Throughout the treatment
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
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

Outcome Measure
Time Frame
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
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
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
Week 9, and every 8 weeks during the extended treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Agensys, Inc.

Investigators

  • Study Director: Use Central Contact, Agensys, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

January 1, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (ESTIMATE)

January 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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