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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00688623 |
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Neuro-Endocrine Non Functioning Neuro-Endocrine Tumors/NET Non Syndromic Neuro-Endocrine Tumors/NET Carcinoids, Non Functioning |
Drug: Everolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single Arm, Multicenter Single Stage Phase II Trial of RAD001 as Monotherapy in the Treatment of Metastatic Non Syndromic Neuro-Endocrine Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: Everolimus |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: Novartis | 41 61 324 1111 |
France | |
Paris, France | |
Bordeaux, France | |
Lyon, France | |
Marseille, France | |
Germany | |
Frankfurt, Germany | |
Munich, Germany | |
Berlin, Germany | |
Bonn, Germany | |
Italy | |
Perugia, Italy | |
Milan, Italy | |
Rome, Italy | |
Poland | |
Warsaw, Poland | |
Spain | |
Barcelona, Spain | |
Madrid, Spain | |
Sweden | |
Stockholm, Sweden | |
United Kingdom | |
London, United Kingdom |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CRAD001CDE16 |
Study First Received: | May 30, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00688623 |
Health Authority: | EU: EMEA |
Neuro-endocrine tumors, non functioning neuro-endocrine tumors, carcinoids, non functioning carcinoids, adults, everolimus |
Everolimus Carcinoma, Neuroendocrine Endocrine System Diseases Carcinoma Neuroendocrine Tumors Carcinoid tumor Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Tumor Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Immunosuppressive Agents Pharmacologic Actions |