EUCTR2013-000672-15-FR进行中（未招募）不适用
A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients who meet all of the following criteria are eligible for enrollment in the trial:
- •a. =18 years of age;
- •b. Diagnosis of MDS according to World Health Organization (WHO) criteria (Appendix 2) or French-American-British (FAB) classification, that must be confirmed by BM aspirate and/or biopsy within 6 weeks prior to Screening;
- •c. MDS classified as Low risk or Int-1 risk, according to IPSS classification; in addition, patients should never have been classified as Int-2 or High-risk since their MDS was diagnosed;
- •d. Transfusion dependency defined by transfusion of at least 4 units of RBC within 56 days (ie, 8 weeks) before Screening (pre-transfusion Hgb values values must be = 9 g/dL to be taken into account);
- •e. Refractory to 8- to 12-week course of ESA administered within the past 2 years before enrollment, or EPO level > 500 mU/mL and off ESA for at least 8 weeks before Screening;
- •f. Off all other treatments for MDS (AZA, decitabine, lenalinomide, ESA, chemotherapy, immunotherapy) for at least 2 weeks prior to Screening;
- •g. ECOG performance status of 0, 1 or 2;
- •h. Willing to adhere to the prohibitions and restrictions specified in this protocol;
- •i. The patient must sign an informed consent form (ICF) indicating that s/he understands the purpose of, and procedures required for, the study and is willing to participate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients with any of the following will not be enrolled in the study:
- •a. Ongoing clinically significant anemia due to factors such as iron, vitamin B12, or folate deficiencies, auto-immune or hereditary hemolysis, or gastrointestinal (GI) bleeding;
- •b. Serum ferritin < 50 ng/mL;
- •c. Hypoplastic MDS (cellularity <10%);
- •d. Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast;
- •e. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
- •f. Active infection not adequately responding to appropriate therapy;
- •g. Total bilirubin = 2.0 mg/dL not related to hemolysis or Gilbert’s disease;
- •h. Alanine transaminase (ALT) or aspartate transaminase (AST) = 2.5 x the upper limit of normal (ULN);
- •i. Serum creatinine = 2.0 mg/dL;
- •j. Ascites requiring active medical management including paracentesis;
- •k. Hyponatremia (defined as serum sodium value of < 130 mEq/L);
- •l. Female patients who are pregnant or lactating;
- •m. Patients who are unwilling to follow strict contraception requirements (including 2 reliable methods in combination: one non-hormonal, highly-reliable method [diaphragm, condoms with spermicidal foam or jelly, or sterilization] plus one additional reliable method [birth control pills, intrauterine device, contraceptive injections, or contraceptive patches]) before entry and throughout the study, up to and including the 30-day nontreatment follow-up period;
- •n. Female patients with reproductive potential who do not have a negative urine pregnancy test at Screening;
- •o. Major surgery without full recovery or major surgery within 3 weeks of Screening;
- •p. Uncontrolled hypertension (defined as a systolic pressure = 160 mmHg and/or a diastolic pressure = 110 mmHg);
- •q. New onset seizures (within 3 months prior to the first dose of rigosertib) or poorly controlled seizures;
- •r. Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy;
- •s. Chronic use (> 2 weeks) of corticosteroids (> 10 mg/24 hr equivalent prednisone) within 4 weeks of Screening;
- •t. Investigational therapy within 4 weeks of Screening;
- •u. Psychiatric illness or social situation that would limit the patient’s ability to tolerate and/or comply with study requirements.
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