Study of BMS-663513 in Patients With Advanced Cancer

Tumors Clinical Trial

Official title:

A Phase I/II, Ascending Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients With Metastatic or Locally Advanced Solid Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00309023
• Other study ID #: CA186-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 29, 2006
• Last updated: September 23, 2015
• Start date: December 2005
• Est. completion date: September 2009

Study information

• Verified date: September 2015
• 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

This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: September 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) score of 0-1.

• Measurable disease.

• Absolute neutrophil count (ANC) >= 1,500 cells/mm3

• Platelet count >= 100K cells/mm3

• Hemoglobin >= 9.0 g/dL

• Total bilirubin <= 1.5 x IULN

• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase <= 2.5 x institutional upper limit of normal (IULN)

• Patients with advanced solid malignancies must have melanoma, renal or ovarian carcinoma

Exclusion Criteria:

• History of autoimmune diseases.

• Condition requiring the continued use of systemic or topical steroids or the use of immunosuppressive agents.

• Active/symptomatic brain metastasis.

• History of hepatitis B or C.

• Concurrent malignancy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• BMS-663513
mg/kg, intravenous (IV), 0.3, 1, 3, 6, 10 or 15 mg/kg, once every 3 weeks (q 3 wks), 12 weeks depending on response

Locations

Country	Name	City	State
Canada	Local Institution	Toronto	Ontario
France	Local Institution	Bordeaux
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Saint Herblain
France	Local Institution	Villejuif Cedex
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	City Of Hope National Medical Center	Duarte	California
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Safety (Number and distribution and severity adverse events) of subjects		Active treatment of a minimum of 3 months up until disease progression or toxicity; and long-term follow-up to assess time to progression or death will conclude 2 years after the last treatment with BMS-663513.	No
Secondary	Efficacy by evaluation of tumor response		At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug	No
Secondary	Assess pharmacokinetic parameters deriving from serum concentration versus time data		Cycle 1 Day 1, Cycle 2 Day 1 and 28, Cycle 3 Day 1 and 8, and Day 1 of every cycle the subject is on study from Cycle 4 and greater; and at study discharge.	No
Secondary	Assess pharmacodynamic and immune response analysis		up to 60 days after last dose of study drug	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