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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00207103
Other study ID # CA182-002
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated November 3, 2008
Start date September 2004
Est. completion date September 2008

Study information

Verified date November 2008
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date September 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Brivanib
Tablets, Oral, 180 mg, once daily, until disease progression
Brivanib
Tablets, Oral, 320 mg, once daily, until disease progression
Brivanib
Tablets, Oral, 600 mg, once daily, until disease progression
Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression
Brivanib
Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression
Brivanab
Tablets, Oral, 1000 mg, once daily, until disease progression

Locations

Country Name City State
Canada Local Institution Edmonton Alberta
Canada Local Institution Ottawa Ontario
Italy Local Institution Milano
United Kingdom Local Institution Manchester Greater Manchester
United Kingdom Local Institution Middlesex Greater London
United States Indiana University Med Center Indianapolis Indiana
United States University Of Wisconsin Comprehensive Center Madison Wisconsin
United States Premiere Oncology Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety assessment throughout the study Yes
Primary dose-limiting toxicity (DLT) assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified Yes
Primary determination of maximum tolerated dose (MTD) 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 Yes
Secondary Efficacy based on duration of response and time to progression based on assessment measured every 8 weeks throughout the study No
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