Study of BMS-663513 in Patients With Advanced Cancer

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Terminated

CT.gov ID

NCT00309023

Collaborator

(none)

115

Enrollment

Locations

Arm

Duration (Months)

9.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tumors	Drug: BMS-663513	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dose escalation	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

Arm

Intervention/Treatment

Experimental: dose escalation

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

Outcome Measures

Primary Outcome Measures

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.]

Secondary Outcome Measures

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]
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.]
Assess pharmacodynamic and immune response analysis [up to 60 days after last dose of study drug]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City Of Hope National Medical Center	Duarte	California	United States	91010
2	Yale University School Of Medicine	New Haven	Connecticut	United States	06520
3	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
6	Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15213
7	Local Institution	Toronto	Ontario	Canada	M5G 2M9
8	Local Institution	Bordeaux		France	33076
9	Local Institution	Paris		France	75004
10	Local Institution	Paris		France	75908
11	Local Institution	Saint Herblain		France	44805
12	Local Institution	Villejuif Cedex		France	94800

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00309023

Other Study ID Numbers:

CA186-001

First Posted:

Mar 31, 2006

Last Update Posted:

Oct 12, 2015

Last Verified:

Sep 1, 2015

Keywords provided by Bristol-Myers Squibb

Advanced Solid Tumors

Study Results

No Results Posted as of Oct 12, 2015