A Study of BMS-663513 Administered in Combination With Ch... | NCT00351325

Studies
A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

NCT00351325

Sponsor

Bristol-Myers Squibb

Status

Terminated

Last Update Posted

Sep 4, 2009Estimated

Enrollment

45Estimated

Phase

Phase 1

Conditions

Advanced Solid Malignancies

Interventions

BMS-663513

Countries

United States
Canada

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 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Estimated

First Submitted Date

Jul 11, 2006

First Submission Date that Met QC Criteria

Jul 11, 2006

First Posted Date

Jul 12, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2009

Last Update Posted Date

Sep 4, 2009Estimated

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 study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given 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

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dose escalation	Experimental		Drug: BMS-663513

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-663513	Drug	mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks	dose escalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies		throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers.		throughout the study
Describe anti-tumor activity		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good activity level
Life expectancy of ≥ 6 months
Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion Criteria:

Major surgery within 4 weeks
Any concurrent cancer
History of autoimmune diseases
Symptomatic bowel obstruction
Continued use of steroids
Symptomatic brain metastases
Current nerve damage in fingers/toes
Positive for HIV, hepatitis B/C
White blood cells < 3,000
Hemoglobin < 9
Platelets < 100,000
ALT/AST and/or alkaline phosphatase >= 2.5 x ULN
Creatine > 1.5
Prior BMS-663513

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
University Of Pennsylvania Medical Center		Philadelphia	Pennsylvania	19104	United States
Magee-Womens Hospital Of Upmc

Intervention Browse Module

MeSH Terms

ID	Term
C000620833	urelumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided