NCT00435669

Brief Summary

The purpose of this trial is to determine the mass balance, pharmacokinetics, metabolism, and routes and extent of elimination of BMS-582664

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 22, 2009

Status Verified

July 1, 2008

Enrollment Period

9 months

First QC Date

February 14, 2007

Last Update Submit

January 21, 2009

Conditions

Tumors

Keywords

Advanced or metastatic solid tumors

Outcome Measures

Primary Outcomes (4)

  • Absorption

    Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

  • Distribution

    Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

  • Metabolism

    Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

  • Elimination of BMS-582664

    Determined by PK measurement collected on Day 1 at timepoints 0 (predose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18 and 24 hour. Continue daily PK collection on Day 2 to Day 10

Secondary Outcomes (1)

  • To assess safety and tolerability of BMS-582664 800 mg administered daily in Part B

    at last patient last visit

Interventions

BrivanibDRUG

Oral Solution, Oral, 800 mg, X1 on Day 1, 10 D for ADME

Also known as: BMS-582664

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
  • Secondary primary malignancy
  • Thromboembolic disease requiring full anticoagulation within 6 months
  • Inability to swallow or absorb oral therapy
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 22, 2009

Record last verified: 2008-07

Locations

US(1)