Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354146
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2006-07-18
Brief Title:
A Phase 2 Study of Farnesyl Transferase Inhibitor R115777 Tipifarnib in Patients With Refractory or Relapsed Acute Myeloid Leukemia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None