- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00093990
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
September 13, 2016 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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])
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
457
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years to 99 years (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (ACTUAL)
October 1, 2007
Study Registration Dates
First Submitted
October 7, 2004
First Submitted That Met QC Criteria
October 8, 2004
First Posted (ESTIMATE)
October 11, 2004
Study Record Updates
Last Update Posted (ESTIMATE)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 13, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004372
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myeloid Leukemia
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Kronos BioActive, not recruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States, Spain
-
Massachusetts General HospitalExelixisCompletedRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
Clinical Trials on Tipifarnib;Zarnestra; R115777
-
National Cancer Institute (NCI)CompletedAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | Adult Acute Myeloid Leukemia With Del(5q) | Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Adult Acute Myeloid Leukemia... and other conditionsUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedBreast CancerUnited Kingdom, United States, France, Russian Federation, Belgium, Netherlands
-
National Cancer Institute (NCI)CompletedRecurrent Adult Acute Myeloid Leukemia | Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monocytic Leukemia (M5b) | Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute... and other conditionsUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedMyelodysplastic Syndrome
-
National Cancer Institute (NCI)CompletedAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome | Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monocytic Leukemia (M5b) | Adult Acute Myeloblastic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedPrimary Myelofibrosis | Polycythemia Vera | Essential ThrombocythemiaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV MelanomaUnited States
-
Kura Oncology, Inc.CompletedLeukemia, Myelomonocytic, ChronicUnited States
-
National Cancer Institute (NCI)TerminatedT-cell Large Granular Lymphocyte Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States