Trial Information

A Randomized Study of Tipifarnib Versus Best Supportive Care (Including Hydroxyurea) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Subjects 70 Years or Older (Farnesyl Transferase Inhibition Global Human Trials AML 301 [F.I.G.H.T. AML 301])

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 patients with leukemia live longer. In this study, half the patients
will receive tipifarnib and half of the patients will receive the standard treatment. The
standard treatment will help to control the symptoms of AML and may include hydroxyurea to
lower levels of circulating leukemia cells. Tipifarnib or the standard treatment will be
given until the patient's leukemia gets better, or until they experience unacceptable side
effects, or until the patient or study doctor decide to stop the study medication. Patients
assigned to tipifarnib will be given tipifarnib tablets. Patients should take 6 tablets with
food in the morning and 6 tablets with food in the evening, for 21 days in a row. Patients
will not take tipifarnib for the next 7 days. This 28 day period is called a cycle. The rest
period may be extended beyond 7 days depending on how well the patients tolerate the
treatment. Patients will return to the study clinic every week and to visit their study
doctor at least every two weeks. A blood draw for routine tests will be done every week.
Depending on how your disease is doing, a bone marrow aspiration may be done at the end of
every cycle. When patients finish treatment with the study medication, or if they leave the
study early, they will be asked to see your doctor for one last visit. Routine laboratory
tests will be done. After this visit the study doctor will continue to check with patients
to see how they are doing and if they have started a new treatment for leukemia. This check
will be made every 30 days and may be made by phone to the patient or to their health care
provider. Tipifarnib; six 100 mg in a film coated, compressed tablets are given orally twice
a day at for 21 consecutive days on a 28-day cycle schedule.