Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Stanford University Genentech Novartis |
---|---|
Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00651482 |
To test whether using bevacizumab and RAD001 together to treat metastatic renal cell cancer is safe and effective.
Condition | Intervention | Phase |
---|---|---|
Kidney Neoplasms |
Drug: RAD001 (Certican) Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RADOO1 |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Signed Informed Consent Form
No more than one prior targeted therapy (e.g. sorafenib, sunitinib)
Exclusion Criteria:DISEASE SPECIFIC EXCLUSIONS
GENERAL MEDICAL EXCLUSIONS
Subjects meeting any of the following criteria are ineligible for study entry:
Inadequate organ function, as evidenced by any of the following at screening:
Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control.
BEVACIZUMAB-SPECIFIC EXCLUSIONS
Known CNS disease, except for treated brain metastasis
RAD001 SPECIFIC EXCLUSIONS
Contact: Denise Haas | (650) 736-1252 | dhaas@stanford.edu |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Denise Haas 650-736-1252 dhaas@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: Dr. Sandy Srinivas | |
Sub-Investigator: Lauren Harshman |
Principal Investigator: | Dr. Sandy Srinivas | Stanford University |
Responsible Party: | Stanford University School of Medicine ( Dr. Sandy Srinivas, Principal Investigator ) |
Study ID Numbers: | SU-01092008-969, 98593, AVF4304s, NCT00651482, RENAL0016 |
Study First Received: | March 28, 2008 |
Last Updated: | August 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00651482 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Everolimus Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Bevacizumab Urologic Neoplasms Angiogenesis Inhibitors Carcinoma |
Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Bevacizumab Urologic Neoplasms Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |