Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT01141569
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.
Study:
NCT01141569
Study Brief:
Protocol Section:
NCT01141569