A Phase 2 Study of Temsirolimus (CCI-779, NSC 683864) and IGF-1 Receptor Antibody Cixutumumab (IMC-A12, NSC 742460) in Patients With Metastatic Sarcomas
I. To determine the proportion of patients progression-free at 12 weeks (PFS, defined as
RECIST 1.1 CR + PR + SD) with (A) IGF-1R+ soft tissue sarcomas; (B) IGF-1R+ bone tumors; or
(C) IGF-1R(-) sarcomas, who are treated weekly with intravenous A12 and temsirolimus.
I. To determine the overall response rate (defined as complete response [CR] + partial
II. To determine the overall survival. III. To determine the correlation of clinical outcome
with pre- and post-treatment IGF-1R pathway related markers in plasma (pre and post
therapy), archived tissue, and pre- and post-treatment tumor biopsies.
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days
1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up for ≥ 4 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate, defined as CR + PR + SD, as assessed by RECIST criteria
For each arm, the response rate will be estimated and a confidence interval will be constructed.
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan Kettering Cancer Center||New York, New York 10021|
|M D Anderson Cancer Center||Houston, Texas 77030|