Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
A Phase 2 Study of RO4929097 (IND 109291) in Patients With Advanced Renal Cell Carcinoma (RCC, NOS 10038415) That Has Progressed After VEGF/VEGFR Directed Therapy
The purpose of this study is to evaluate the activity of RO4929097 in renal cell carcinoma patients that have failed therapy with VEGF/VEGFR directed agents.
PRIMARY OBJECTIVES:
I. To assess the objective response rate of RO4929097 in patients with advanced kidney
cancer and failure of anti-VEGF directed therapy.
SECONDARY OBJECTIVES:
I. To assess the antitumor activity of RO4929097 through secondary endpoints including:
duration of radiologic response, rate of disease stabilizations, rate of tumor control rate
(CR+PR+SD), and progression-free & overall survival rates.
II. To assess the safety and tolerability of single agent RO4929097 in patients with
advanced RCC.
III. To explore expression of Notch biomarkers in RCC patients and their potential
interaction with RO4929097 response and toxicity.
OUTLINE:
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) on
days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 12
months.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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