NCT00390936

Brief Summary

The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Typical duration for phase_1

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

October 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 25, 2011

Status Verified

March 1, 2010

Enrollment Period

2.4 years

First QC Date

October 20, 2006

Last Update Submit

January 24, 2011

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity

    at the end of the first cycle of the study

  • Maximum Tolerated Dose

    at the end of the first cycle of the study

Secondary Outcomes (1)

  • To assess any preliminary evidence of anti-tumor activity observed with BMS-582664

    at the end of the study

Study Arms (1)

1

NO INTERVENTION

4 dosages

Drug: Brivanib

Interventions

BrivanibDRUG

Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity

Also known as: BMS-582664
1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have measurable disease
  • Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator
  • ECOG PS: 0-1

You may not qualify if:

  • Subjects with centrally located squamous cell carcinoma of the lung

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Sunto-Gun, Shizuoka, 411-8777, Japan

Location

Related Links

MeSH Terms

Interventions

brivanib

Study Officials

  • Bristol-Myers Squibb

    Bristol Myers

    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

October 20, 2006

First Posted

October 23, 2006

Study Start

October 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 25, 2011

Record last verified: 2010-03

Locations

JP(1)