NCT00461110

Brief Summary

The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

4 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

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

April 13, 2007

Last Update Submit

September 3, 2009

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma

    throughout the study

Secondary Outcomes (4)

  • Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers

    end of study

  • Describe anti-tumor activity

    throughout the study

  • Obtain blood and plasma for exploratory research

    several timepoints throughout the study

  • Obtain archival tissue for predictive marker research

    at screening

Study Arms (2)

1

EXPERIMENTAL

Active

Drug: BMS-663513

2

EXPERIMENTAL

Active

Drug: BMS-663513

Interventions

BMS-663513DRUG

mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks

Also known as: Anti-CD137
12

Eligibility Criteria

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

You may qualify if:

  • NSCLC who are eligible to receive a 6 week course of RT
  • Part 1 - not candidates for definitive RT
  • Part 2 - candidates for definitive RT

You may not qualify if:

  • Severe COPD, pulmonary infection or interstitial pneumonitis
  • Recent cellulitis
  • Autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Cancer Institute Of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Nyu Clinical Cancer Center

New York, New York, 10016, United States

Location

Thomas Jefferson Univ Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University Of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

urelumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

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

April 13, 2007

First Posted

April 17, 2007

Study Start

January 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

US(4)