DRKS00011259招募中3 期
Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent - 04-30 (INSPIRE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 81 Years（—）
- 性别
- All
入选标准
- •a. 18-81 years of age;
- •b. Disease classification and cytogenetics confirmed within 8 weeks prior to or during screening
- •as follows:
- •RAEB-1 per World Health Organization (WHO) MDS criteria (5% to <10% BM blasts)
- •RAEB-2 per WHO MDS criteria (10% to <20% BM blasts)
- •RAEB-t per modified French-American-British (FAB) classification (20% to 30% BM
- •c. At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL)
- •d. Progression (according to 2006 IWG criteria) at any time after initiation of AZA or DAC
- •Failure to achieve complete or partial response or hematological improvement (HI) (according
- •to 2006 IWG) after at least six 4-week cycles of AZA or either four 4-week or four 6-week
- •cycles of DAC administered
- •Relapse after initial complete or partial response or HI (according to 2006 IWG criteria)
- •Intolerance to AZA or DAC
- •e. Total duration of prior HMA therapy = 9 months
- •f. Last dose of AZA or DAC within 6 months before the planned date of randomization; however,
- •must be off these treatments for = 4 weeks before randomization
- •g. Has failed to respond to, relapsed following, not eligible for, or opted not to participate in
- •allogeneic stem cell transplantation
- •h. Off all treatments for MDS (including AZA and DAC) for = 4 weeks before randomization;
- •growth factors (G-CSF, erythropoietin and TPO) and transfusions are allowed before and
- •during the study as clinically indicated
- •i. Patients with 5q- syndrome should have failed to respond to or progressed on treatment with
- •lenalidomide
- •j. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •k. Willing to adhere to the prohibitions and restrictions specified in this protocol
- •l. Patient (or patient’s legally authorized representative) must have signed an informed consent
- •document indicating that the patient understands the purpose of and procedures required for the
- •study and is willing to participate in the study.
排除标准
- •a. Previous participation in a clinical study of IV or oral rigosertib; patients who failed screening
- •for other rigosertib studies may be screened for participation in this study
- •b. Eligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3
- •days of an anthracycline, or high-dose cytarabine (HDAC)
- •c. Patient previously diagnosed with AML (defined as a bone marrow blast percentage of
- •d. Suitable candidate to receive allogeneic stem cell transplantation; patient is eligible for study if
- •a suitable candidate refuses to undergo an allogeneic stem cell transplant or a suitable donor
- •cannot be found.
- •e. Any active malignancy within the past year, except basal cell or squamous cell skin cancer or
- •carcinoma in situ of the cervix or breast
- •f. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart
- •failure or unstable angina pectoris
- •g. Active infection not adequately responding to appropriate therapy
- •h. Total bilirubin =1.5 mg/dL not related to hemolysis or Gilbert’s disease
- •i. Alanine transaminase (ALT)/aspartate transaminase (AST) =2.5 x upper limit of normal (ULN)
- •j. Serum creatinine =2.0 mg/dL
- •k. Known HIV, hepatitis B or hepatitis C
- •l. Uncorrected hyponatremia (defined as serum sodium value of <130 mEq/L)
- •m. Female patients of child-bearing potential (pre-menopausal and not surgically sterilized) who
- •are breast-feeding or have a positive blood beta-human chorionic gonadotropin (ßHCG)
- •pregnancy test at Screening
- •n. Female patients of child-bearing potential and male patients with partners of child-bearing
- •potential who are unwilling to follow strict contraception requirements before entry and
- •throughout the study, up to and including the 30-day non-treatment follow-up period
- •o. Major surgery without full recovery or major surgery within 3 weeks before planned
- •randomization
- •p. Uncontrolled hypertension
- •q. New onset seizures (within 3 months before planned randomization) or poorly controlled
- •r. Any other concurrent investigational agent or chemotherapy, radiotherapy, immunotherapy, or
- •corticosteroids (prednisone up to 20 mg/day or its equivalent is permitted for chronic
- •conditions)
- •s. Treatment with cytarabine at any dose, lenalidomide, or any other therapy targeted to the
- •treatment of MDS (other than growth factors and other supportive care measures) within
- •4 weeks of planned randomization
- •t. Investigational therapy within 4 weeks of planned randomization
- •u. Psychiatric illness or social situation that would limit the patient’s ability to tolerate and/or
- •comply with study requirements.
研究者
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