A Study of RO4929097 in Patients With Advanced Renal Cell Carcinoma That Have Failed Vascular Endothelial Growth Factor (VEGF)/Vascular Endothelial Growth Factor Receptor (VEGFR) Therapy
|Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Carcinoma Stage IV Renal Cell Cancer||Drug: Gamma-Secretase Inhibitor RO4929097 Other: Laboratory Biomarker Analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Objective Response Rate (PR + CR) Using RECIST [ Time Frame: Up to 12 months ]
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
- Time to Progression [ Time Frame: Up to 12 months ]Time to Progression is duration of time from start of treatment to time of progression
- Frequency and Severity of Adverse Events [ Time Frame: Up to 12 months ]Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
- Progression-free Survival Rate [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 12 months ]Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Rate of Disease Stabilizations [ Time Frame: Up to 12 months ]Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
- Tumor Control Rate (CR + PR + SD) [ Time Frame: Up to 12 months ]Tumor control rate is defined as the sum of objective response rate (CR+PR) and stable disease (SD) rate.
|Study Start Date:||June 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (RO4929097)
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.
Drug: Gamma-Secretase Inhibitor RO4929097
Other Name: RO4929097Other: Laboratory Biomarker Analysis
I. To assess the objective response rate of RO4929097 in patients with advanced kidney cancer and failure of anti-VEGF directed therapy.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141569
|Canada, British Columbia|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Health Research Institute-General Division|
|Ottawa, Ontario, Canada, K1H 1C4|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Christian Kollmannsberger||University Health Network-Princess Margaret Hospital|