EUCTR2021-001838-19-CZ进行中（未招募）1 期
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 141
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
- •1. Diagnosis of MDS (Parts 1 and 2) according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
- •2. < 5% blasts in bone marrow during the Pretreatment Period.
- •3. Peripheral blood white blood cell (WBC) count < 13,000/µL during the Pretreatment Period.
- •4. Anemia defined as:
- •a. In LTB participants, having received 1 to 3 units of RBCs for Hgb = 9.0 g/dL within 8 weeks of the Pretreatment Period OR
- •b. In HTB participants (defined as requiring > or = 4 units of RBCs for hemoglobin < or = 9.0 g/dL within 8 weeks)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).
- •6. Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.
- •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 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1. Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
- •2. Diagnosis of secondary MDS (ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- •3. Vitamin B12 deficiency.
- •4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- •5. Treatment with ESA within 56 days prior to C5D1.
- •6. Prior or concurrent chronic treatment with G-CSF or GM-CSF.
- •7. Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
- •8. Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
- •9. Treatment with another investigational drug or device or approved therapy for investigational use < or = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
- •10. Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
- •11. Transferrin saturation < 15%.
- •12. Ferritin < 50 µg/L.
- •13. Folate < 4.5 nmol/L (< 2.0 ng/mL).
- •14. Vitamin B12 < 148 pmol/L (< 200 pg/mL).
- •15. Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
- •16. Pregnant or lactating females.
- •Medical History
- •Diagnosis of MDS with deletion of chromosome 5q (Del5q).
- •Presence of uncontrolled heart disease or New York Heart Association Class III or IV heart failure.
- •Presence of uncontrolled hypertension (Grade = 2 high blood pressure).
- •History of stroke, deep venous thrombosis, or arterial embolism within 6 months prior to C1D1(or C5D1 for the Part 1 Extension).
- •Any malignancy other than MDS that has not been in remission and/or has required systemictherapy 1 year prior to C1D1 (or C5D1 for the Part 1 Extension).
- •Diagnosis of secondary MDS.
- •History of solid organ or hematological transplantation
- •Body mass index = 40 kg/m2.
- •Treatment History
- •Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- •Treatment with ESA within 8 weeks prior to C1D1 (or C5D1 for the Part 1 Extension).
- •Prior or concurrent chronic treatment with granulocyte colony-stimulating factor (G-CSF) orgranulocyte-macrophage colony-stimulating factor (GM-CSF), for reasons other than thetreatment of MDS.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)EUCTR2021-001838-19-ESKeros Therapeutics, Inc.104
招募中
2 期
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)Myelodysplastic SyndromesBlood - AnaemiaBlood - Haematological diseasesBlood - Normal development and function of platelets and erythrocytesACTRN12620000696998Keros Therapeutics Australia Pty Ltd54
进行中（未招募）
1 期
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS).MedDRA version: 27.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2021-001838-19-DEKeros Therapeutics, Inc.141
未知
2 期
A dose finding study of KRN125Chemotherapy-induced neutropeniaJPRN-jRCT2080220922Kyowa Hakko Kirin Co., Ltd.
未知
2 期
A phase 2 dose exploratory study of K-877DyslipidemiaJPRN-jRCT2080221294Kowa Co., Ltd.192