Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047190
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-10-03
Brief Title:
Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of R115777 in Myelofibrosis With Myeloid Metaplasia MMM
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of tipifarnib in treating patients who have myelofibrosis with myeloid metaplasia Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response rate in MMM patients treated with R115777 II To evaluate the toxicity of R115777 in patients with MMM
SECONDARY OBJECTIVES
I To evaluate the benefit of therapy with R115777 in alleviating disease-associated anemia in patients with MMM
II To evaluate the benefit of R115777 in reducing palpable splenomegaly in patients with MMM
III To evaluate the effect of R115777 on the hypercatabolic symptoms from MMM IV To evaluate the effect of R115777 on the pathologic increase in circulating myeloid progenitors in MMM patients through baseline measurement and measurement after the first cycle
V To correlate responserelapse with in vitro myeloid colony sensitivity to R115777 at the time of either response or relapse
VI To evaluate the effect of R115777 on bone marrow histologic features of MMM including osteosclerosis reticulin fibrosis and angiogenesis through serial bone marrow microvessel density grading
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study within 15 months
I To evaluate the response rate in MMM patients treated with R115777 II To evaluate the toxicity of R115777 in patients with MMM
SECONDARY OBJECTIVES
I To evaluate the benefit of therapy with R115777 in alleviating disease-associated anemia in patients with MMM
II To evaluate the benefit of R115777 in reducing palpable splenomegaly in patients with MMM
III To evaluate the effect of R115777 on the hypercatabolic symptoms from MMM IV To evaluate the effect of R115777 on the pathologic increase in circulating myeloid progenitors in MMM patients through baseline measurement and measurement after the first cycle
V To correlate responserelapse with in vitro myeloid colony sensitivity to R115777 at the time of either response or relapse
VI To evaluate the effect of R115777 on bone marrow histologic features of MMM including osteosclerosis reticulin fibrosis and angiogenesis through serial bone marrow microvessel density grading
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study within 15 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM17104 | NIH | None | httpsreporternihgovquickSearchN01CM17104 |
| MC0184 | None | None | None |