- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00354146
A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.
January 31, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
252
Phase
- Phase 2
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- .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.
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: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this 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
April 1, 2001
Study Completion (ACTUAL)
July 1, 2003
Study Registration Dates
First Submitted
July 18, 2006
First Submitted That Met QC Criteria
July 18, 2006
First Posted (ESTIMATE)
July 20, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
February 1, 2011
Last Update Submitted That Met QC Criteria
January 31, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004036
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.
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