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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00412061 |
The purpose of this study is to evaluate whether everolimus 10 mg / day added to treatment with octreotide depot prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.
Condition | Intervention | Phase |
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Carcinoid Tumor Malignant Carcinoid Syndrome |
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 Placebo-Controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo |
Estimated Enrollment: | 390 |
Study Start Date: | December 2006 |
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
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CRAD001C2325 |
Study First Received: | December 13, 2006 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00412061 |
Health Authority: | United States: Food and Drug Administration |
Cancer Carcinoid Tumor Neuroendocrine |
Carcinoma Everolimus Octreotide |
Everolimus Serotonin Syndrome Poisoning Octreotide Disorders of Environmental Origin Malignant Carcinoid Syndrome Carcinoid syndrome Carcinoma Neuroendocrine Tumors |
Carcinoid tumor Neuroectodermal Tumors Drug Toxicity Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Tumor Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Disease Antineoplastic Agents, Hormonal Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue |
Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses |