A Phase I Study of BMS-690514 in Combination With Paclita... | NCT00420186

Studies
A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin

NCT00420186

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Sep 30, 2016Estimated

Enrollment

37Actual

Phase

Phase 1

Conditions

Cancer (Solid Tumors)

Interventions

BMS-690514

Countries

United States
Canada
United Kingdom

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

May 2014

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

Oct 2007

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jan 8, 2007

First Submission Date that Met QC Criteria

Jan 8, 2007

First Posted Date

Jan 9, 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

Sep 28, 2016

Last Update Posted Date

Sep 30, 2016Estimated

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 clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin

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

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: BMS-690514

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-690514	Drug	Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation		upon occurrence

Secondary Outcomes

Measure	Description	Time Frame
Describe anti-tumor activity		upon occurence
Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research		upon occurence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
Centrally located squamous cell carcinoma of the lung is permitted
ECOG performance status of 0-1
Life expectancy of at least 3 months
Men and women age 18 and above

Exclusion Criteria:

Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
Peripheral neuropathy ≥Grade 1 for any reason
History of thromboembolic disease or bleeding diatheses within the last 6 months
Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
Serious, uncontrolled medical disorder or active infection
Uncontrolled or significant cardiac disease
Uncontrolled hypertension (150/100)
Allergy to Cremophor EL®

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
Roswell Park Cancer Institute		Buffalo	New York	14263	United States
Penn State Milton S. Hershey Medical Center