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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00702052 |
Purpose
This study is to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in patients with Mantle Cell Lymphoma who are refractory or intolerant to Velcade® therapy and who have received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy is determined by the study investigator based on clinical evaluations. Patients are considered refractory to Velcade® if they have documented radiological progression on or within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of the last dose of the last component of a combination therapy which included Velcade®.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Mantle- Cell |
Drug: RAD001 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Single-arm Phase II Study of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® (Bortezomib). |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RAD001 | Drug: RAD001 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 37 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00702052 History of Changes |
| Other Study ID Numbers: | CRAD001N2201 |
| Study First Received: | June 19, 2008 |
| Last Updated: | January 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Mantle Cell Lymphoma Lymphoma B-Cell Lymphoma Mantle Zone Lymphoma |
Refractory Lymphoma Aggressive Lymphoma PILLAR-1 |
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |