Status:
COMPLETED
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
70-99 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effectiveness of tipifarnib in patients aged 70 or more with acute myeloid leukemia. Tipifarnib belongs to a class of drugs called Farnesyl Transferase In...
Detailed Description
This study tests the safety and effectiveness of the experimental drug, tipifarnib in older patients who have acute myeloid leukemia (AML). The purpose of this study is to test if tipifarnib can make ...
Eligibility Criteria
Inclusion
- Newly diagnosed or re-lapsing AML
- Patient not medically fit for combination induction chemotherapy
- Pathologic confirmation of AML (= or \> 20% bone marrow leukemic blasts)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Exclusion
- Previous cytotoxic or biologic treatment for AML
- Acute promyelocytic leukemia (APL)
- Central nervous system leukemia
- Uncontrolled systemic infection
- Uncompensated disseminated intravascular coagulation
- Symptomatic neuropathy of grade 2 or worse
- Known allergy to imidazole drugs.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT00093990
Start Date
January 1 2004
End Date
October 1 2007
Last Update
September 14 2016
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