A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

September 3, 2009 updated by: Bristol-Myers Squibb

A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMC
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

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

All

Description

Inclusion Criteria:

  • Good activity level
  • Life expectancy of ≥ 6 months
  • Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion Criteria:

  • Major surgery within 4 weeks
  • Any concurrent cancer
  • History of autoimmune diseases
  • Symptomatic bowel obstruction
  • Continued use of steroids
  • Symptomatic brain metastases
  • Current nerve damage in fingers/toes
  • Positive for HIV, hepatitis B/C
  • White blood cells < 3,000
  • Hemoglobin < 9
  • Platelets < 100,000
  • ALT/AST and/or alkaline phosphatase >= 2.5 x ULN
  • Creatine > 1.5
  • Prior BMS-663513

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dose escalation
Drug: BMS-663513
mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers.
Time Frame: throughout the study
throughout the study
Describe anti-tumor activity
Time Frame: throughout the study
throughout the study
Obtain tissue or ascites for exploratory research
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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

September 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

July 11, 2006

First Submitted That Met QC Criteria

July 11, 2006

First Posted (Estimate)

July 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 4, 2009

Last Update Submitted That Met QC Criteria

September 3, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA186-004

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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