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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207103
First received: September 12, 2005
Last updated: November 3, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Tumors
Neoplasm Metastasis
Drug: Brivanib
Drug: Brivanab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety assessment [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy based on duration of response and time to progression based on assessment [ Time Frame: measured every 8 weeks throughout the study ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: September 2004
Study Completion Date: September 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
Other Name: BMS-582664
Experimental: 2 Drug: Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
Other Name: BMS-582664
Experimental: 3 Drug: Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
Other Name: BMS-582664
Experimental: 4 Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
Other Name: BMS-582664
Experimental: 5 Drug: Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Other Name: BMS-582664
Experimental: 6 Drug: Brivanab
Tablets, Oral, 1000 mg, once daily, until disease progression
Other Name: BMS-582664

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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 ClinicalTrials.gov identifier: NCT00207103

Locations
United States, California
Premiere Oncology
Santa Monica, California, United States, 90404
United States, Indiana
Indiana University Med Center
Indianapolis, Indiana, United States, 46202
United States, Wisconsin
University Of Wisconsin Comprehensive Center
Madison, Wisconsin, United States, 53792
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 1C4
Italy
Local Institution
Milano, Italy, 20141
United Kingdom
Local Institution
Middlesex, Greater London, United Kingdom, HA6 2RN
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00207103     History of Changes
Other Study ID Numbers: CA182-002
Study First Received: September 12, 2005
Last Updated: November 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced metastatic or solid tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014