Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of California, San Francisco Novartis |
---|---|
Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00384969 |
The objective of the phase I part of the study is to determine the maximum tolerated dose and dose limiting toxicities of the combination of RAD001 and sorafenib in patients with untreated metastatic kidney cancer. Phase II part of the study will determine safety, response rate,progression free survival and time to disease progression in kidney cancer patients.
Condition | Intervention | Phase |
---|---|---|
Renal Cell Carcinoma |
Drug: RAD001 and Sorafenib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Phase I/II Study of Sorafenib and RAD001 in Patients With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 73 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
RAD001 and Sorafenib
|
Drug: RAD001 and Sorafenib
RAD001 2.5mg to 10.0mg PO QD Sorafenib 400mg PO BID
|
Phase I of the study will be an open-label dose escalation study to determine the MTD of the combination of sorafenib and RAD001. There will be a 7-day sorafenib run-in period prior to starting of RAD001 during cycle 1 to determine the pharmacokinetic effect of adding RAD001 on sorafenib drug levels. Starting doses will be set at RAD001 2.5 mg PO QD and sorafenib 400mg PO BID, continuously. Cycle length will be 4 weeks. Between 3 and 18 patients will be treated in the phase I portion of this study.
In Phase II, 49 patients will be treated at the RP2D of the combination of RAD001 and sorafenib (including the 6 patients treated at the MTD on the phase I portion of this study). Patients will take the RP2 doses of sorafenib PO BID and RAD001 PO QD. Drug dosing will continue until disease progression or unacceptable toxicity.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow function:
Adequate hepatic function:
Adequate renal function as determined by either:
Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used) Modified Cockcroft-Gault formula: ((140 - age(yrs)) x (actual weight(kg))) / (72 x serum creatinine(mg/dl))
* Multiply by another factor of 0.85 if female
Exclusion Criteria:
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Julie Russell, RN 415-353-7085 julie.russell@ucsfmedctr.org | |
Contact: Jay Trovato, RN 415-353-9268 jay.trovato@ucsfmedctr.org | |
Principal Investigator: Andrea Harzstark, MD |
Principal Investigator: | Andrea Harzstark, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Andrea Harzstark, MD ) |
Study ID Numbers: | UCSF06523 |
Study First Received: | October 3, 2006 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00384969 |
Health Authority: | United States: Food and Drug Administration |
RAD001 Sorafenib Renal Cell Carcinoma Metastatic |
Everolimus Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents Pharmacologic Actions |