A Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1 Study of BMS-663513 in Combination With Chemoradiation in Subjects With Non Small Cell Lung Carcinoma (NSCLC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00461110
• Other study ID #: CA186-005
• Status: Terminated
• Phase: Phase 1
• First received: April 13, 2007
• Last updated: September 3, 2009
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: September 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe COPD, pulmonary infection or interstitial pneumonitis

• Recent cellulitis

• Autoimmune disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• BMS-663513
mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks

Locations

Country	Name	City	State
United States	University Of Texas Southwestern Medical Center	Dallas	Texas
United States	The Cancer Institute Of New Jersey	New Brunswick	New Jersey
United States	Nyu Clinical Cancer Center	New York	New York
United States	Thomas Jefferson Univ Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers		end of study	No
Secondary	Describe anti-tumor activity		throughout the study	No
Secondary	Obtain blood and plasma for exploratory research		several timepoints throughout the study	No
Secondary	Obtain archival tissue for predictive marker research		at screening	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm