Study of BMS-582664 in Combination With Either FOLFIRI or... | NCT00300027

Studies
Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies

NCT00300027

Sponsor

Bristol-Myers Squibb

Status

Terminated

Last Update Posted

Mar 2, 2010Estimated

Enrollment

Phase

Phase 1

Conditions

Gastrointestinal Neoplasms

Interventions

BMS-582664

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Not provided

First Submitted Date

Mar 6, 2006

First Submission Date that Met QC Criteria

Mar 6, 2006

First Posted Date

Mar 8, 2006Estimated

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

Feb 27, 2010

Certification/Extension First Submitted that Passed QC Review

Feb 27, 2010

Certification/Extension First Posted Date

Mar 2, 2010Estimated

Last Update Submitted Date

Feb 27, 2010

Last Update Posted Date

Mar 2, 2010Estimated

Description Module

Brief Summary

The purpose of this study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.

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

Name	Type	Description	Arm Group Labels	Other Names
BMS-582664	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
Echocardiogram every 2 cycles (q 2 cycles)

Secondary Outcomes

Measure	Description	Time Frame
Tumor response (q 2 cycles)
PK parameters (during 1st cycle)
PD markers (weekly)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good performance status
Advanced colorectal, pancreatic, esophageal or gastric cancer
Tissue for analyses
Adequate bone marrow, hepatic, renal function
4-6 weeks since prior therapy
Adequate protection for women of child bearing potential (WOCBP)

Exclusion Criteria:

Brain metastasis
Thromboembolic disease
Cardiovascular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Little Rock	Arkansas		United States
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

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