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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00410124 |
To assess whether daily treatment with everolimus can slow the growth and spread of metastatic carcinoma of the kidney. The safety of everolimus will also be studied in this trial.
Condition | Intervention | Phase |
---|---|---|
Metastatic Renal Cell Carcinoma |
Drug: everolimus |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of Everolimus Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor |
Estimated Enrollment: | 362 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CRAD001C2240 |
Study First Received: | December 11, 2006 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00410124 History of Changes |
Health Authority: | United States: Food and Drug Administration |
advanced kidney cancer everolimus kidney cancer oral therapy |
Everolimus Urinary Tract Neoplasm Kidney Cancer Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Immunosuppressive Agents Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Sunitinib Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Everolimus Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Immunosuppressive Agents Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |