Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00117598 |
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: Temsirolimus (CCI-779) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Randomized, Phase 3 Trial of Intravenous Temsirolimus (CCI-779) at Two Dose Levels Compared to Investigator's Choice Therapy in Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL) |
Estimated Enrollment: | 177 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Temsirolimus (CCI-779)
1 (175/25 mg TEMSR), 2 (175/25 mg TEMSR), 3 (Investigator's Choice)
|
B: Experimental |
Drug: Temsirolimus (CCI-779)
1 (175/25 mg TEMSR), 2 (175/25 mg TEMSR), 3 (Investigator's Choice)
|
C |
Drug: Temsirolimus (CCI-779)
1 (175/25 mg TEMSR), 2 (175/25 mg TEMSR), 3 (Investigator's Choice)
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:
Exclusion Criteria:
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3066K1-305 |
Study First Received: | June 30, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00117598 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lymphoma |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Mantle-Cell Mantle Cell Lymphoma |
Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |