NCT00387426终止2 期
A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants With Objective Clinical Response to Sunitinib Therapy
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
详细描述
PRIMARY OBJECTIVE:
I. Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate.
SECONDARY OBJECTIVE:
I. Assess the safety of sunitinib malate in these patients.
OUTLINE: This is an open-label, multicenter study.
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
- •Diagnosis of MF (histologically confirmed) requiring therapy, including those previously treated and relapsed or refractory (no more than one prior standard acute leukemia-type chemotherapy regimen; no limit on prior MF - directed therapies) or if newly diagnosed, with intermediate or high risk according to Lille scoring system (adverse prognostic factors are: Hb < 10 g/dl, WBC < 4 or > 30 x 10^9/L; risk group: 0 = low, 1 = intermediate, 2 = high), or with symptomatic organomegaly.
- •Serum bilirubin levels </= 2x upper limit of the normal (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or MF
- •Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels </= 2x ULN. Higher levels are acceptable if these can be attributed to MF.
- •Serum creatinine levels </= 2x ULN.
- •Eighteen years of age or older.
- •ECOG performance status 0-1 (Karnofsky </= 70%).
- •Patients must have QTc < 500 msec
- •Women of childbearing potential and men must agree to use adequate contraception (e.g. hormonal or barrier method of birth control; abstinence) for the duration of study participation. All women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document
- •Both men and women and members of all races and ethnic groups are eligible for this trial.
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to beginning treatment or those who have not recovered from treatment-limiting adverse events (to grade 1 or better) due to agents administered more than 4 weeks earlier. At least 4 weeks must have elapsed since any major surgery prior to study enrollment. Continuous use of supportive care medications (i. e. growth factors, anagrelide, or hydroxyurea) is allowed.
- •Patients may not be receiving any other investigational agents.
- •Patients who have received prior treatment with any other specific antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.) targeting VEGF/VEGFR system. Other agents that may have some antiangiogenic effects are allowed). (i.e. thalidomide)
- •Patients with abnormal QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or patients who have a history of serious ventricular arrhythmia (VT or VF>/= 3 beats in a row or other significant (as judged by treating physician) ECG abnormalities.Patients with consistently poorly controlled (during the month prior to study screening) hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) despite appropriate medical management of the hypertension.
- •Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin. Exceptions include: patients using warfarin of up to 2 mg daily for prophylaxis of thrombosis, and patients using low molecular weight heparin provided the patient's INR is </= 1.
- •Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets.
- •Patients with any of the following conditions:·Serious or non-healing wound, ulcer, or bone fracture, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment,·cerebrovascular accident (CVA) or transient ischemic attack, myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting, or pulmonary embolism within 12 months prior to study,·Class III or IV heart failure as defined by the NYHA functional classification system.
- •Because sunitinib is metabolized primarily by the CYP3A4 liver enzyme, the eligibility of patients taking medications that are potent inducers or inhibitors of that enzyme will be determined following a review of their case by the Principal Investigator. Every effort should be made to switch patients taking such agents or substances to other medications.
- •Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medications.
- •Patients with uncontrolled intercurrent illness (as judged by treating physician) including, but not limited to, ongoing or active infections requiring IV antibiotics.
- •Pregnant women are excluded from this study because sunitinib is an antiangiogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib, breastfeeding should be discontinued if the mother is treated with sunitinib malate.
- •HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
研究组 & 干预措施
Arm I
Experimental
Patients receive oral sunitinib malate once daily for 6 weeks.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Number of Participants With Objective Clinical Response to Sunitinib Therapy
时间窗: After two 6-week treatment courses (12 weeks)
Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemiade Novo Myelodysplastic SyndromesMyelodysplastic SyndromesSecondary Myelodysplastic SyndromesChronic Myelomonocytic LeukemiaNCT00451048National Cancer Institute (NCI)10
已完成
2 期
Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the UterusRecurrent Uterine SarcomaUterine LeiomyosarcomaNCT00378911National Cancer Institute (NCI)44
已完成
2 期
Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid CancerRecurrent Thyroid CancerStage IVA Follicular Thyroid CancerStage IVA Papillary Thyroid CancerStage IVB Follicular Thyroid CancerStage IVB Papillary Thyroid CancerStage IVC Follicular Thyroid CancerStage IVC Papillary Thyroid CancerThyroid Gland Medullary CarcinomaNCT00519896University of Washington35
已完成
2 期
A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary GlandsSalivary Gland CancerAdenoid Cystic CarcinomaNCT00886132University Health Network, Toronto14
已完成
2 期
Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaB-cell Chronic Lymphocytic LeukemiaRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaNCT00398112National Cancer Institute (NCI)18