MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

November 3, 2008 updated by: Bristol-Myers Squibb

Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1C4
        • Local Institution
  • Italy
      • Milano, Italy, 20141
        • Local Institution
  • United Kingdom
    • Greater London
      • Middlesex, Greater London, United Kingdom, HA6 2RN
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Premiere Oncology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Med Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin Comprehensive Center

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:

  • Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
  • No tumor spread to the brain
  • Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
  • Available tumor tissue sample from prior surgery
  • 4-6 weeks since prior therapy and recovered from prior therapy
  • Men and women, ages 18 and above
  • Women must not be pregnant or breastfeeding
  • Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
  • Measurable disease on scans (at least one)

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: 1
Drug: Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Other Names:
  • BMS-582664
Experimental: 2
Drug: Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Other Names:
  • BMS-582664
Experimental: 3
Drug: Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Other Names:
  • BMS-582664
Experimental: 4
Drug: Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Other Names:
  • BMS-582664
Experimental: 5
Drug: Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
Other Names:
  • BMS-582664
Drug: Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Other Names:
  • BMS-582664
Experimental: 6
Drug: Brivanab
Tablets, Oral, 1000 mg, once daily, until disease progression
Other Names:
  • BMS-582664

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessment
Time Frame: throughout the study
throughout the study
dose-limiting toxicity (DLT)
Time Frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
Time Frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy based on duration of response and time to progression based on assessment
Time Frame: measured every 8 weeks throughout the study
measured every 8 weeks 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, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 4, 2008

Last Update Submitted That Met QC Criteria

November 3, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA182-002

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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