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

Primary Purpose

Tumors, Neoplasm Metastasis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Brivanib
Brivanib
Brivanib
Brivanib
Brivanib
Brivanab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumors focused on measuring Advanced metastatic or solid tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Premiere Oncology
  • Indiana University Med Center
  • University Of Wisconsin Comprehensive Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

Outcomes

Primary Outcome Measures

Safety assessment
dose-limiting toxicity (DLT)
determination of maximum tolerated dose (MTD)

Secondary Outcome Measures

Efficacy based on duration of response and time to progression based on assessment

Full Information

First Posted
September 12, 2005
Last Updated
November 3, 2008
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00207103
Brief Title
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Neoplasm Metastasis
Keywords
Advanced metastatic or solid tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 180 mg, once daily, until disease progression
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 320 mg, once daily, until disease progression
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 600 mg, once daily, until disease progression
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 800 mg, once daily, until disease progression
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Intervention Type
Drug
Intervention Name(s)
Brivanab
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 1000 mg, once daily, until disease progression
Primary Outcome Measure Information:
Title
Safety assessment
Time Frame
throughout the study
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Efficacy based on duration of response and time to progression based on assessment
Time Frame
measured every 8 weeks throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Premiere Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Indiana University Med Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Of Wisconsin Comprehensive Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution
City
Middlesex
State/Province
Greater London
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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