A Phase I Study to Determine the Effect of Food on Brivan... | NCT00437437

Studies
A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)

NCT00437437

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jun 21, 2013Estimated

Enrollment

29Actual

Phase

Phase 1

Conditions

Tumors

Interventions

Brivanib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2000

Primary Completion Date

May 2008Actual

Completion Date

Feb 2013Actual

First Submitted Date

Feb 14, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2013

Last Update Posted Date

Jun 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Brivanib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brivanib	Drug	Tablet, Oral, Brivanib 800 mg, QD after single dose Pk comparison of food effect, until progression	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

Histologic/cytologic diagnosis of advanced or metastatic solid tumors
ECOG 0-2
4/6 weeks since prior therapy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber Harvard Cancer Care		Boston	Massachusetts	02115	United States
Wayne State University

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C509922	brivanib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided