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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00702052 |
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
---|---|
RAD001: Experimental | Drug: RAD001 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are considered refractory to Velcade®, if Velcade® is part of a combination treatment for the disease.
Exclusion Criteria:
Contact: Novartis Pharmaceuticals | +1 800-340-6843 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CRAD001N2201 |
Study First Received: | June 19, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00702052 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Mantle Cell Lymphoma Lymphoma B-Cell Lymphoma Mantle Zone Lymphoma |
Refractory Lymphoma Aggressive Lymphoma PILLAR-1 |
Everolimus Immunoproliferative Disorders Immunologic Factors Lymphoma, Mantle-Cell Bortezomib Mantle Cell Lymphoma Immunosuppressive Agents |
Lymphoma, B-Cell Lymphatic Diseases B-cell Lymphomas Aggression Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Everolimus Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Lymphoma, Mantle-Cell Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |