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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Malignancies

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

throughout the study

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA186-004

NCT ID:

NCT00351325

Start Date:

September 2007

Completion Date:

March 2009

Related Keywords:

  • Advanced Solid Malignancies
  • Neoplasms

Name

Location
University of Washington Seattle, Washington  98195
University of Virginia Charlottesville, Virginia  22908
University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104
Magee-Womens Hospital of UPMC Pittsburgh, Pennsylvania  15213