Conditions: Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: Gamma-Secretase Inhibitor RO4929097 intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol document: