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

Advanced Solid Malignancies Clinical Trial

Official title:

A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00351325
• Other study ID #: CA186-004
• Status: Terminated
• Phase: Phase 1
• First received: July 11, 2006
• Last updated: September 3, 2009
• Start date: September 2007
• Est. completion date: March 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 assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

Drug:
• BMS-663513
mg/kg, IV, 0.3, 1, 3, 10 mg/kg, q 3 wks, up to 24 weeks

Locations

Country	Name	City	State
Canada	Local Institution	Toronto	Ontario
United States	University Of Virginia	Charlottesville	Virginia
United States	University Of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Magee-Womens Hospital Of Upmc	Pittsburgh	Pennsylvania
United States	University Of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers.		throughout the study	No
Secondary	Describe anti-tumor activity		throughout the study	No
Secondary	Obtain tissue or ascites for exploratory research		throughout the study	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