EUCTR2020-002771-35-IT进行中（未招募）1 期
A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma - INCB00928-105
INCYTE CORPORATIO0 个研究点目标入组 80 人开始时间: 2021年5月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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. Ability to comprehend and willingness to sign a written ICF for the study.
- •2. Age 18 years or older at the time of signing the ICF.
- •3. ECOG performance status of the following:
- •a. 0 or 1 for the dose-escalation stages.
- •b. 0, 1, or 2 for the dose-expansion stage.
- •4. Life expectancy > 6 months.
- •5. Agreement to avoid pregnancy or fathering children based on the criteria below:
- •a. Men must agree to take appropriate precautions to avoid fathering children from screening through 90 days after the last dose of study drug
- •and must refrain from donating sperm during this period.
- •b. Women with childbearing potential must have a negative serum pregnancy test at
- •screening before the first dose must agree to take appropriate precautions to avoid pregnancy from screening through the safety follow-up visit, and must not donate oocytes during this period.
- •c. Women without childbearing potential are eligible.
- •6. Participants who are transfusion-dependent or present with symptomatic anemia, defined as follows:
- •a. Anemia: an Hgb value < 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements
- •b. Transfusion-dependent: participant has received at least 4 units of RBC transfusions
- •during the 28 days immediately preceding C1D1 OR has received at least 4 units of RBC transfusions in the 8 weeks immediately preceding C1D1, for an Hgb level of
- •< 8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
- •7. Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide.
- •8. Not requiring cytoreductive therapy other than hydroxyurea.
- •9. BM and peripheral blood myeloblast count < 10%.
- •10. Histologically confirmed diagnosis of the following (according to the 2016 WHO criteria:
- •c. Unclassifiable MDS/MPN overlap syndromes
- •11. Histologically confirmed diagnosis of MM
- •12. After failure of available standard treatments
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
- •2. Any major surgery within 28 days before the first dose of study drug.
- •3. Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
- •a. Exceptions include glucocorticoids and hydroxyurea
- •4. Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug.
- •5. Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug.
- •6. Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study
- •7. Any prior radiation therapy within 28 days before the first dose of study drug.
- •8. Presence of any hematologic malignancy other than MDS or MM, as applicable.
- •9. Active invasive malignancy over the previous 5 years
- •10. Known active disease involving the CNS.
- •11. History of clinically significant or uncontrolled cardiac disease
- •12. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
- •13. Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- •14. Diagnosis of chronic liver disease
- •15. Known active hepatitis A, HBV, or HCV infection or known HIV infection.
- •16. Unwillingness to be undergo transfusion with blood components, including RBC packs and platelet transfusions.
- •17. Any condition in the investigator's judgment that would interfere with full participation in the study including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- •18. Active alcohol or drug addiction that would interfere with the participant's ability to comply with the study requirements.
- •19. Gastroesophageal reflux disease not controlled by medication within 28 days before the first dose of study drug.
- •20. Presence of any unresolved toxicity => Grade 2 from previous therapy except for stable chronic toxicities (=< Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
- •21. Known hypersensitivity, severe reaction, or any known contraindications to the use of any of the active substances or excipients in INCB000928.
- •22. Women who are pregnant or breastfeeding.
- •23. Unable to swallow and retain oral medication.
- •24. Current use of prohibited medication
- •25. Participants with laboratory values at screening as defined in the protocol
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