Clinical trial NCT00309023: Study of BMS-663513 in Patients With Advanced Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Tumors
Keywords: Advanced Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-03-31
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assess Safety (Number and distribution and severity adverse events) of subjects
timeFrame: 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 outcomes:
measure: Efficacy by evaluation of tumor response
timeFrame: At week 12 and every 6 weeks thereafter. Follow-up up to 2 years after last dose of study drug
measure: Assess pharmacokinetic parameters deriving from serum concentration versus time data
timeFrame: 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.
measure: Assess pharmacodynamic and immune response analysis
timeFrame: up to 60 days after last dose of study drug
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City Of Hope National Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Bordeaux
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Saint Herblain
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: