NCT00437437

Brief Summary

The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2000

Longer than P75 for phase_1

Geographic Reach
1 country

3 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

May 1, 2000

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

8 years

First QC Date

February 14, 2007

Last Update Submit

June 20, 2013

Conditions

Tumors

Keywords

Advanced or metastatic solid tumors

Outcome Measures

Primary Outcomes (1)

  • To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a high fat meal versus administration in a fasted state

    throughout the study

Secondary Outcomes (1)

  • To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal

    throughout the study

Study Arms (1)

1

EXPERIMENTAL
Drug: Brivanib

Interventions

BrivanibDRUG

Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression

Also known as: BMS-582664
1

Eligibility Criteria

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

You may qualify if:

  • Histologic/cytologic diagnosis of advanced or metastatic solid tumors
  • ECOG 0-2
  • /6 weeks since prior therapy

You may not qualify if:

  • Brain metastases
  • Second primary malignancy
  • Thromboembolic disease requiring full anticoagulation within 6 months
  • Inability to swallow or absorb oral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dana-Farber Harvard Cancer Care

Boston, Massachusetts, 02115, United States

Location

Wayne State University

Detroit, Michigan, 48201-2194, United States

Location

Duke University Medical Center-Dept Of Medicine

Durham, North Carolina, 27710, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

brivanib

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 21, 2007

Study Start

May 1, 2000

Primary Completion

May 1, 2008

Study Completion

February 1, 2013

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

US(3)