An Open-Label, Phase 1/Phase 2, Single-Agent Study of CEP-32496 in Patients With Advanced Solid Tumors in Phase 1 and in Patients With Advanced Melanoma and Metastatic Colorectal Cancer With BRAF Mutation in Phase 2
The primary objective of Phase 1 is to determine the recommended Phase 2 dose (RP2D) of
CEP-32496. The primary objective of Phase 2 is to evaluate the antitumor activity of
CEP-32496 at the RP2D, as assessed by objective response rate (complete response [CR] or
partial response [PR]) using Response Evaluation Criteria in Solid Tumors version 1.1
(RECIST v1.1) in patients with advanced unresectable melanoma and metastatic colorectal
cancer with BRAF mutation. Four groups of patients will be treated in Phase 2:
- group A: patients with advanced unresectable melanoma with acquired resistance to BRAF
inhibitors (ie, patients who have achieved a CR or PR as a best response to treatment
with a prior BRAF inhibitor and subsequently became resistant) and patients who
discontinued treatment with a BRAF inhibitor due to intolerance
- group B: patients with advanced unresectable melanoma with primary resistance to BRAF
inhibitors (ie, patients who maintained stable disease or had progressive disease as a
best response to treatment with a prior BRAF inhibitor)
- group C: patients with advanced unresectable melanoma who are naïve to treatment with
BRAF inhibitors
- group D: patients with metastatic colorectal cancer who are naïve to treatment with
BRAF inhibitors
Each phase of this study will consist of a 28-day screening period. Patients will be treated
in 28-day treatment cycles until disease progression, unacceptable toxicity, withdrawal of
consent, or protocol specified parameters to stop treatment. Patients in Phase 1 will be
followed for a minimum of 6 months after the last dose of study treatment, and patients in
Phase 2 will be followed to collect further anticancer information for up to 12 months after
the end-of-treatment visit for the last discontinued patient on the study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
The primary efficacy variable is the objective response rate calculated as the number of responders (i.e., CR or PR) in each patient group divided by the number of evaluable patients in that patient group.
Approximately 12 months
No
United States: Food and Drug Administration
C32496/1105
NCT01877811
June 2013
April 2017
Name | Location |
---|---|
Teva Investigational Site 10672 | Duarte, California |
Teva Investigational Site 10673 | Fort Myers, Florida |
Teva Investigational Site 10670 | Detroit, Michigan |
Teva Investigational Site 10671 | St. Louis, Missouri |
Teva Investigational Site 10669 | Philadelphia, Pennsylvania |