Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-30 @ 3:01 AM
Study NCT ID:
NCT01141569
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2010-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-03068 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| PHL-077 | OTHER | University Health Network-Princess Margaret Hospital | View | |
| 8563 | OTHER | CTEP | View | |
| N01CM00032 | NIH | None | https://reporter.nih.gov/quic… | View |