NCT00351325

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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
2 countries

5 active sites

Status
terminated

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

July 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

July 11, 2006

Last Update Submit

September 3, 2009

Conditions

Advanced Solid Malignancies

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 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

  • Obtain tissue or ascites for exploratory research

    throughout the study

Study Arms (1)

dose escalation

EXPERIMENTAL
Drug: BMS-663513

Interventions

BMS-663513DRUG

mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks

dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Magee-Womens Hospital Of Upmc

Pittsburgh, Pennsylvania, 15213, United States

Location

University Of Virginia

Charlottesville, Virginia, 22908, United States

Location

University Of Washington

Seattle, Washington, 98109, United States

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

urelumab

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 12, 2006

Study Start

September 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

US(4)CA(1)