Acute Myeloid LeukemiaPhase 3NCT00093990
Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
A Phase 3 study testing Tipifarnib;Zarnestra; R115777 in people with Acute Myeloid Leukemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Tipifarnib;Zarnestra; R115777
- How many people
- 457 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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])
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Tipifarnib;Zarnestra; R115777
- Keywords
- Myeloid leukemia acute disease, Tipifarnib, Bone marrow aspirate
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipifarnib;Zarnestra; R115777Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2004 (estimated)
- Study startJan 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093990
- Sponsor's protocol ID
- CR004372
- Status last verified
- Sep 2016
- First submitted
- 7 Oct 2004
- Last updated
- 14 Sep 2016
- Results posted
- No
Publications
Harousseau JL, Martinelli G, Jedrzejczak WW, Brandwein JM, Bordessoule D, Masszi T, Ossenkoppele GJ, Alexeeva JA, Beutel G, Maertens J, Vidriales MB, Dombret H, Thomas X, Burnett AK, Robak T, Khuageva NK, Golenkov AK, Tothova E, Mollgard L, Park YC, Bessems A, De Porre P, Howes AJ; FIGHT-AML-301 Investigators. A randomized phase 3 study of tipifarnib compared with best supportive care, including hydroxyurea, in the treatment of newly diagnosed acute myeloid leukemia in patients 70 years or older. Blood. 2009 Aug 6;114(6):1166-73. doi: 10.1182/blood-2009-01-198093. Epub 2009 May 21.
PubMed 19470696
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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])
- ClinicalTrials.gov ID
- NCT00093990
- Acronym / sponsor ID
- CR004372
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Myeloid leukemia acute disease, Tipifarnib, Bone marrow aspirate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Previous cytotoxic or biologic treatment for AML
- Acute promyelocytic leukemia (APL)
- Central nervous system leukemia
- Uncontrolled systemic infection
- Uncompensated disseminated intravascular coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tipifarnib;Zarnestra; R115777 | Drug | – |
Primary outcome
Overall survival
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Derived from this study: PubMed 19470696Harousseau JL, Martinelli G, Jedrzejczak WW, Brandwein JM, Bordessoule D, Masszi T, Ossenkoppele GJ, Alexeeva JA, Beutel G, Maertens J, Vidriales MB, Dombret H, Thomas X, Burnett AK, Robak T, Khuageva NK, Golenkov AK, Tothova E, Mollgard L, Park YC, Bessems A, De Porre P, Howes AJ; FIGHT-AML-301 Investigators. A randomized phase 3 study of tipifarnib compared with best supportive care, including hydroxyurea, in the treatment of newly diagnosed acute myeloid leukemia in patients 70 years or older. Blood. 2009 Aug 6;114(6):1166-73. doi: 10.1182/blood-2009-01-198093. Epub 2009 May 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tipifarnib;Zarnestra; R115777 in people with Acute Myeloid Leukemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00093990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.