NCT00047190已完成2 期
A Phase II Trial of R115777 in Myelofibrosis With Myeloid Metaplasia (MMM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Confirmed response defined as the objective status of complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 4 weeks apart
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologic confirmation (on bone marrow trephine and aspirate) of myelofibrosis with myeloid metaplasia by a pathologist/hematologist at the registering institution; included in the diagnosis of MMM are AMM (agnogenic myeloid metaplasia), PPMM (post-polycythemic myeloid metaplasia), and PTMM (post-thrombocythemic myeloid metaplasia); the bone marrow should show the presence of reticulin fibrosis, and the peripheral blood smear should show the presence of leukoerythroblastosis and dacrocytosis
- •Bone marrow showing no evidence of other conditions associated with myelofibrosis, such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7 type), or acute myelofibrosis
- •Bone marrow chromosome analysis or peripheral blood or bone marrow Fluorescent In Situ Hybridization (FISH) showing absence of chromosomal translocation t(9:22); prior demonstration is sufficient for enrollment purposes
- •At least one of the following:
- •Anemia evidenced by hemoglobin < 10 g/dL
- •Palpable hepato-splenomegaly
- •ANC ≥ 750/mm^3
- •PLT ≥ 100,000/mm^3
- •Total bilirubin (direct if total elevated) ≤ UNL
- •Alkaline phosphatase =< 3 x UNL (unless felt to be secondary to disease)
- •AST ≤ 2.5 x UNL
- •Creatinine =< 1.5 x UNL
- •Ability to understand and the willingness to sign a written informed consent document
- •Willingness to follow the schedule for returning to the registering P2C institution (monthly) while receiving protocol treatment
- •ECOG performance status 0, 1, or 2
排除标准
- •Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- •Pregnant women
- •Breastfeeding women
- •Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- •NOTE: The effects of the agent(s) on the developing human fetus at the recommended therapeutic dose are unknown
- •Use of cytotoxic chemotherapy or other myelosuppressive agents within =< 2 weeks prior to study entry
- •Uncontrolled intercurrent illness or any co-morbid condition that would limit compliance with study requirements or with which the use of R115777 is felt to be potentially harmful; such conditions include, but are not limited to:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia, or
- •Psychiatric illness/social situations
- •Other concurrent therapy directed at the disease (including Thalidomide) or use of erythropoietin while enrolled in this study; such agents must be discontinued at the time of or prior to study entry
- •Known quinolone sensitivity
研究组 & 干预措施
Arm I
Experimental
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.
干预措施: tipifarnib (Drug)
Arm I
Experimental
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.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Confirmed response defined as the objective status of complete response (CR) or partial response (PR) on 2 consecutive evaluations at least 4 weeks apart
时间窗: Up to 2 years
Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
次要结局
- Overall survival(Time from registration to death due to any cause, assessed up to 2 years)
- Time to progression(Time from registration to the time of progression, assessed up to 2 years)
- Duration of response(Date of complete response to the date progression is documented (if one has occurred) or to the date of last follow-up (for those patients who have not progressed), assessed up to 2 years)
研究者
研究点 (1)
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