Status:
COMPLETED
A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Leukemia, Nonlymphocytic, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML.
Detailed Description
Acute myeloid leukemia (AML) accounts for approximately 25% of all cases of leukemia diagnosed in the Western hemisphere. First-line chemotherapy regimens induce complete remissions in 55-75% of patie...
Eligibility Criteria
Inclusion
- Refractory or relapsed Acute myeloid leukemia (AML)
- Eastern Cooperative Oncology Group (ECOG) performance of 0-2
- any value of WBC
- able to eat food and medication orally
- females must use contraception and not be pregnant
Exclusion
- .Not in another study with an investigational agent within 3 weeks of tipifarnib administration
- must not have active CNS leukemia
- must not have disseminated intravascular coagulation (DIC) disorder with evidence of hemorrhage
- must not be allergic to imidazole drugs such as ketoconazole, miconazole, econazole, or terconazole.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00354146
Start Date
April 1 2001
End Date
July 1 2003
Last Update
February 1 2011
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