Leukemia, Nonlymphocytic, AcutePhase 2NCT00354146
A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.
A Phase 2 study testing tipifarnib (R115777) in people with Leukemia, Nonlymphocytic, Acute, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Nonlymphocytic, Acute
- What is being tested?
- tipifarnib (R115777)
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Jul 2003
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory or relapsed Acute myeloid leukemia (AML)
- Eastern Cooperative Oncology Group (ECOG) performance of 0-2
- any value of WBC
- able to eat food and medication orally
- females must use contraception and not be pregnant
Who cannot join
- .Not in another study with an investigational agent within 3 weeks of tipifarnib administration
- must not have active CNS leukemia
- must not have disseminated intravascular coagulation (DIC) disorder with evidence of hemorrhage
- must not be allergic to imidazole drugs such as ketoconazole, miconazole, econazole, or terconazole.
About this study
Official title: A Phase 2 Study Evaluating the Efficacy of the Farnesyl Transferase Inhibitor (FTI) R115777 in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML.
Read the detailed description
Acute myeloid leukemia (AML) accounts for approximately 25% of all cases of leukemia diagnosed in the Western hemisphere. First-line chemotherapy regimens induce complete remissions in 55-75% of patients. However, between 50% and 70% of patients who achieve remission will relapse. Current therapy for patients refractory to initial therapy or who relapse within 6 months of remission is unsatisfactory because complete remission rates are low and remission duration is brief. New drugs with novel mechanisms of action may be more beneficial than the currently available ones. Tipifarnib represents a new class of oncology drugs which have a specific cellular target (inhibition of the farnesyl transferase protein), one of the components of the Ras oncogene, as its specific mechanism of acton. It is believed that inhibition of this protein will lead to a decrease of cellular proliferation or cell death. This is an open-label, multicenter, non-comparative phase 2 study investigating the efficacy and safety of farnesyl transferase inhibition with tipifarnib administered orally as a single agent, twice daily, for the first 21 days of every 28 day cycle. Patients are enrolled by disease status into two cohorts; Cohort 1 includes patients with relapsed AML and Cohort 2, patients with refractory AML. All patients will be treated for a sufficient length of time to determine response to study medication (effectiveness) by evaluating the rate of complete remission (CR) or complete remission with incomplete platelet recovery (CRp), duration of complete remission, time to disease progression and progression-free survival, overall survival, and to characterize clinical benefit and quality of life (QOL). The safety profile of tipifarnib will also be determined in patients with refractory of relapsed AML.. The patients will receive six tablets (100 mg each) of tipifarnib twice daily for 21 of 28 day cycles (7 day rest period between cycles). Patients may receive tipifarnib until disease progression or unacceptable toxicity occurs.
- Conditions
- Leukemia, Nonlymphocytic, Acute
- Being tested
- tipifarnib (R115777)
- Keywords
- Farnesyl transferase inhibitor, relapsed or refractory acute myeloid leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tipifarnib (R115777)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective is to determine the rate of complete remission or complete remission with incomplete platelet recovery induced by tipifarnib in patients with refractory or relapsed AML treated until disease progression or unacceptable toxicity occurs.
Secondary outcomes (1)
These objectives are to determine the objective remission rate, duration of remission, time to disease progression/progression-free survival, overall survival, and the clinical benefit/quality of life (QOL). The safety profile will also be determined.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startApr 2001
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Nonlymphocytic, AcuteStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 252 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
- NCT00354146
- Sponsor's protocol ID
- CR004036
- Status last verified
- Jan 2011
- First submitted
- 18 Jul 2006
- Last updated
- 1 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Evaluating the Efficacy of the Farnesyl Transferase Inhibitor (FTI) R115777 in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00354146
- Acronym / sponsor ID
- CR004036
- Conditions
- Leukemia, Nonlymphocytic, Acute
- Keywords
- Farnesyl transferase inhibitor, relapsed or refractory acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Jul 2003 (actual)
- First posted
- 20 Jul 2006 (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 evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML.
Detailed description
Acute myeloid leukemia (AML) accounts for approximately 25% of all cases of leukemia diagnosed in the Western hemisphere. First-line chemotherapy regimens induce complete remissions in 55-75% of patients. However, between 50% and 70% of patients who achieve remission will relapse. Current therapy for patients refractory to initial therapy or who relapse within 6 months of remission is unsatisfactory because complete remission rates are low and remission duration is brief. New drugs with novel mechanisms of action may be more beneficial than the currently available ones. Tipifarnib represents a new class of oncology drugs which have a specific cellular target (inhibition of the farnesyl transferase protein), one of the components of the Ras oncogene, as its specific mechanism of acton. It is believed that inhibition of this protein will lead to a decrease of cellular proliferation or cell death. This is an open-label, multicenter, non-comparative phase 2 study investigating the efficacy and safety of farnesyl transferase inhibition with tipifarnib administered orally as a single agent, twice daily, for the first 21 days of every 28 day cycle. Patients are enrolled by disease status into two cohorts; Cohort 1 includes patients with relapsed AML and Cohort 2, patients with refractory AML. All patients will be treated for a sufficient length of time to determine response to study medication (effectiveness) by evaluating the rate of complete remission (CR) or complete remission with incomplete platelet recovery (CRp), duration of complete remission, time to disease progression and progression-free survival, overall survival, and to characterize clinical benefit and quality of life (QOL). The safety profile of tipifarnib will also be determined in patients with refractory of relapsed AML.. The patients will receive six tablets (100 mg each) of tipifarnib twice daily for 21 of 28 day cycles (7 day rest period between cycles). Patients may receive tipifarnib until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Refractory or relapsed Acute myeloid leukemia (AML)
- Eastern Cooperative Oncology Group (ECOG) performance of 0-2
- any value of WBC
- able to eat food and medication orally
- females must use contraception and not be pregnant
Key exclusion criteria (4 listed)
- .Not in another study with an investigational agent within 3 weeks of tipifarnib administration
- must not have active CNS leukemia
- must not have disseminated intravascular coagulation (DIC) disorder with evidence of hemorrhage
- must not be allergic to imidazole drugs such as ketoconazole, miconazole, econazole, or terconazole.
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 (R115777) | Drug | – |
Primary outcome
The objective is to determine the rate of complete remission or complete remission with incomplete platelet recovery induced by tipifarnib in patients with refractory or relapsed AML treated until disease progression or unacceptable toxicity occurs.
1 secondary outcome
These objectives are to determine the objective remission rate, duration of remission, time to disease progression/progression-free survival, overall survival, and the clinical benefit/quality of life (QOL). The safety profile will also be determined.
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 1 Feb 2011.
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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 2 study testing tipifarnib (R115777) in people with Leukemia, Nonlymphocytic, Acute, 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 5 inclusion and 4 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 1 Feb 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The objective is to determine the rate of complete remission or complete remission with incomplete platelet recovery induced by tipifarnib in patients with refractory or relapsed AML treated until disease progression or unacceptable toxicity occurs.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2011.