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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00048503 |
The purpose of this study is to determine if giving tipifarnib after standard treatment will prevent leukemia from coming back (relapsing). Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Drug: ZARNESTRA, tipifarnib, R115777 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Phase 2 Study of the Farnesyl Transferase Inhibitor ZARNESTRA (R115777) as Post-Consolidation Therapy for Acute Myeloid Leukemia (AML) in Patients Age 60 Years and Older. |
Enrollment: | 88 |
Study Start Date: | June 2002 |
Study Completion Date: | November 2005 |
The study is an open-label evaluation of treatment with tipifarnib in approximately 127 subjects, 60 years and older, with AML in complete remission (CR) after consolidation therapy. Prior to enrollment, patients will receive 1 or 2 cycles of induction chemotherapy. Patients who attain a CR will receive 1 or 2 cycles of consolidation chemotherapy. Patients in postconsolidation complete remission who meet the eligibility criteria are offered enrollment in the study. Subjects enrolled in the study are treated with tipifarnib A dose-modification scheme is followed to maintain adequate specified laboratory values and to minimize other adverse events. Postconsolidation treatment with tipifarnib continues until the time of relapse, death, completion of 24 cycles of treatment, or discontinuation as advised by study doctor.
Tipifarnib, film coated, compressed tablets containing 100 mg active drug, will be administered orally at a dose of 300 mg (three 100 mg film coated tablets) taken twice a day for 21 consecutive days on a 28-day cycle schedule for up to 24 months.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004033 |
Study First Received: | November 1, 2002 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00048503 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Zarnestra Acute myeloid leukemia Tipifarnib |
Leukemia Acute Myelocytic Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Tipifarnib |
Leukemia Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Leukemia, Myeloid Leukemia, Myeloid, Acute Pharmacologic Actions Tipifarnib |