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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00510068 |
The purpose of this study is to evaluate progression free survival in those assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors
Condition | Intervention | Phase |
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Advanced Neuroendocrine Tumors |
Drug: Everolimus |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) |
Estimated Enrollment: | 392 |
Study Start Date: | July 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Other protocol defined inclusion/ exclusion criteria may apply
Contact: Novartis US | 1 800 340 6843 | |
Contact: Novartis Basel | 41 61 324 1111 |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CRAD001C2324 |
Study First Received: | July 31, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00510068 |
Health Authority: | United States: Food and Drug Administration |
Phase III Advanced Neuroendocrine Tumor in adults RAD001 NET |
Everolimus Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Neuroendocrine Tumors |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Immunosuppressive Agents Pharmacologic Actions |