EUCTR2013-001124-19-IT进行中（未招募）1 期
Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients with Myelodysplastic Syndrome with Excess Blasts Progressing On or After azacitidine or decitabine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •a. =18 years of age;
- •b. Diagnosis of MDS confirmed within 6 weeks prior to Screening according to WHO criteria or FAB classification;
- •c. MDS classified as follows, according to WHO criteria and FAB classification:
- •RAEB-1 (5% to 9% BM blasts)
- •RAEB-2 (10% to 19% BM blasts)
- •CMML (10% to 20% BM blasts) and white blood cells (WBC) < 13,000/µL
- •RAEB-t (20% to 30% BM blasts), meeting the following criteria:
- •- WBC < 25 x 10e9/L at study entry
- •- Stable WBC at least 4 weeks prior to Screening and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukophoresis;
- •d. At least one cytopenia (ANC < 1800/µL or PLT count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL);
- •e. Progression (according to 2006 IWG criteria) at any time after initiation of subcutaneous or intravenous AZA or DEC treatment per labeling during the past 2 years, defined as follows:
- •For patients with < 5% BMBL, = 50% increase in BMBL to > 5% BMBL
- •For patients with 5-10% BMBL, = 50% increase in BMBL to > 10% BMBL
- •For patients with 10-20% BMBL, = 50% increase in BMBL to > 20% BMBL
- •For patients with 20-30% BMBL, = 50% increase in BMBL to > 30% BMBL
- •Any of the following:
- •- = 50% decrease from maximum remission/response levels in granulocytes or PLT
- •- Decrease in Hgb concentration by = 2 g/dL
- •- Transfusion dependence, defined as administration of at least 4 RBC units in the past 8 weeks before Screening (patients must have Hgb values < 9 g/dL prior to transfusion to be considered), in the absence of another explanation.
- •f. Has failed to respond to, relapsed following, not eligible, or opted not to participate in BM transplantation;
- •g. Off all other treatments for MDS for at least 4 weeks, except for AZA or DEC. Filgrastim (G-CSF) and EPO are allowed before and during the study as clinically indicated;
- •h. No medical need for induction chemotherapy;
- •i. ECOG performance status of 0, 1 or 2;
- •j. Willing to adhere to the prohibitions and restrictions specified in this protocol;
- •k. 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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •a. Previous participation in a clinical study of IV or oral rigosertib;
- •b. Anemia due to factors other than MDS (including hemolysis or gastrointestinal [GI] bleeding) unless stabilized for 1 week after RBC transfusion;
- •c. Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast;
- •d. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
- •e. Active infection not adequately responding to appropriate therapy;
- •f. Total bilirubin = 1.5 mg/dL not related to hemolysis or Gilbert’s disease;
- •g. ALT/AST = 2.5 x upper limit of normal (ULN);
- •h. Serum creatinine = 2.0 mg/dL;
- •i. Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of < 130 mEq/L);
- •j. Female patients who are pregnant or lactating;
- •k. 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;
- •l. Female patients with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin (ßHCG) pregnancy test at Screening;
- •m. Major surgery without full recovery or major surgery within 3 weeks of Baseline/Cycle 1 Day 1 (C1D1) visit;
- •n. Uncontrolled hypertension (defined as a systolic pressure =160 mmHg and/or a diastolic pressure = 110 mmHg);
- •o. New onset seizures (within 3 months prior to Baseline/C1D1) or poorly controlled seizures;
- •p. Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy;
- •q. Prior treatment with low-dose cytarabine during the past 2 years;
- •r. Investigational therapy within 4 weeks of Baseline/C1D1 visit;
- •s. Psychiatric illness or social situation that would limit the patient’s ability to tolerate and/or comply with study requirements.
研究者
相似试验
进行中（未招募）
1 期
A study to assess the efficacy and safety of rigosertib given by continuous intravenous infusion for 72 hours in patients with a blood disease called myelodysplastic syndrome who have failed azacitidine or decitabine treatmentsMedDRA version: 18.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Myelodysplastic SyndromeEUCTR2013-001124-19-DEOnconova Therapeutics, Inc.90
进行中（未招募）
1 期
A study to assess the efficacy and safety of rigosertib given by continuous intravenous infusion for 72 hours in patients with a blood disease called myelodysplastic syndrome who have failed azacitidine or decitabine treatmentsMyelodysplastic SyndromeEUCTR2013-001124-19-SEOnconova Therapeutics, Inc.90
进行中（未招募）
1 期
A study to assess the efficacy and safety of rigosertib given by continuous intravenous infusion for 72 hours in patients with a blood disease called myelodysplastic syndrome who have failed azacitidine or decitabine treatmentsMyelodysplastic SyndromeEUCTR2013-001124-19-DKOnconova Therapeutics, Inc.90
进行中（未招募）
1 期
A study to assess the efficacy and safety of rigosertib given by continuous intravenous infusion for 72 hours in patients with a blood disease called myelodysplastic syndrome who have failed azacitidine or decitabine treatmentsMedDRA version: 16.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Myelodysplastic SyndromeEUCTR2013-001124-19-ESOnconova Therapeutics, Inc.90
进行中（未招募）
1 期
A clinical trial of midostaurin in adult patients = 18 years old with newly diagnosed acute myeloid leukemia (AML). Patients must have a mutation known as FLT3 and eligible for 7+3 or 5+2 chemotherapyEUCTR2016-004440-12-ESovartis Farmacéutica, S.A.300