Treatment of Acute Myeloid Leukemia (AML)
Conditions
Interventions
Product Name: Zarnestra 100mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: tipifarnib
Current Sponsor code: R115777
Other descriptive name: (R)-6-[amino(4-chlorophenyl)(1-methyl1H-imidazol
Sponsors
Johnson & Johnson Pharmaceutical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 70 years of age or older- Newly diagnosed, de novo or secondary AML- Subject not medically fit for, or does not wish to be treated with, combination induction chemotherapy- Pathologic confirmation of AML (>20% bone marrow leukemic blasts)- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (recorded on day of randomization)- Subject has signed the informed consent document. Consent may not be given by a legal representative. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous cytotoxic or biologic treatment for AML- Acute promyelocytic leukemia (APL) - Absolute peripheral blast count >30,000/mm3 - Central nervous system leukemia- Serum biochemical values as follows: Creatinine clearance (calculated by Cockcroft-Gault formula) less than 60ml/min Total bilirubin greater than 1.5 times ULN (CTC Grade 1) ALT (alanine transaminase) and AST (aspartate transaminase) greater than 2.5 times ULN (CTC Grade 1)- Uncontrolled systemic infection- Uncompensated disseminated intravascular coagulation or uncontrolled bleeding- Symptomatic neuropathy of grade 2 or worse- Known allergy to imidazole drugs, such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, ticonazole or terconazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare overall survival of subjects treated with tipifarnib with that of subjects treated with best supportive care including hydroxyurea. ;Secondary Objective: (1) to compare the following end points between subjects treated with tipifarnib and subjects treated with best supportive care including hydroxyurea.- Progression-Free Survival (PFS)- Complete remission (CR) rate- Rate of morphologic leukemia-free state- One-year survival estimate- Health resources utilization, including: Duration of hospitalization Hospitalization for infections Blood product transfusion(2) to characterize the safety profile of tipifarnib.(3) to characterize potential genetic markers that may be predictive of response to tipifarnib ;Primary end point(s): Overall survival | — |
Countries
Czech Republic, Denmark, Germany, Hungary, Ireland, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed