Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00093990

Collaborator

(none)

457

Enrollment

Duration (Months)

Study Details

Study Description

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 Inhibitors (FTI). It blocks proteins that make leukemia cells grow.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Tipifarnib;Zarnestra; R115777	Phase 3

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

457 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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])

Study Start Date :

Jan 1, 2004

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Overall survival []

Secondary Outcome Measures

Compare patients treated with tipifarnib and patients treated with best supportive care: progression-free survival; complete remission rate; rate of morphologic leukemia-free state; one-year survival estimate and health resources utilization. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.