NCT00207103

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 4, 2008

Status Verified

November 1, 2008

Enrollment Period

3.1 years

First QC Date

September 12, 2005

Last Update Submit

November 3, 2008

Conditions

TumorsNeoplasm Metastasis

Keywords

Advanced metastatic or solid tumors

Outcome Measures

Primary Outcomes (3)

  • Safety assessment

    throughout the study

  • 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

  • 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

Secondary Outcomes (1)

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

    measured every 8 weeks throughout the study

Study Arms (6)

1

EXPERIMENTAL
Drug: Brivanib

2

EXPERIMENTAL
Drug: Brivanib

3

EXPERIMENTAL
Drug: Brivanib

4

EXPERIMENTAL
Drug: Brivanib

5

EXPERIMENTAL
Drug: Brivanib

6

EXPERIMENTAL
Drug: Brivanab

Interventions

BrivanibDRUG

Tablets, Oral, 180 mg, once daily, until disease progression

Also known as: BMS-582664
1
BrivanabDRUG

Tablets, Oral, 1000 mg, once daily, until disease progression

Also known as: BMS-582664
6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Indiana University Med Center

Indianapolis, Indiana, 46202, United States

Location

University Of Wisconsin Comprehensive Center

Madison, Wisconsin, 53792, United States

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution

Ottawa, Ontario, K1H 1C4, Canada

Location

Local Institution

Milan, 20141, Italy

Location

Local Institution

Middlesex, Greater London, HA6 2RN, United Kingdom

Location

Local Institution

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

brivanib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

September 1, 2004

Primary Completion

October 1, 2007

Study Completion

September 1, 2008

Last Updated

November 4, 2008

Record last verified: 2008-11

Locations

CA(2)GB(2)IT(1)US(3)