NL-OMON48784撤回不适用
Phase I, international, multicentre, open-label, non-randomised, non-comparative study of intravenously administered S64315, a Mcl1-inhibitor, in patients with Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS) - CL1-64315-001
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 8
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female aged * 18 years old.
- •2. Patients with cytologically confirmed and documented de novo, secondary or
- •therapy-related AML excluding acute promyelocytic leukaemia:
- •* with relapsed or refractory disease without established alternative therapy or
- •* secondary to MDS treated at least by hypomethylating agent and without
- •established alternative therapy or
- •* > 65 years not previously treated for AML and who are not candidates for
- •intensive chemotherapy nor candidates for established alternative chemotherapy
- •Patients with cytologically confirmed and documented MDS in relapse or
- •refractory after previous treatment line including at least one
- •hypomethylating agent and have *10% bone marrow blasts and who are not
- •candidates for any established alternative therapy.
- •3. ECOG performance status 0 to 2
- •4. Circulating white blood cells < 10.109/L
- •5. Adequate renal function
- •6. LDH < 2 x ULN
- •7. Adequate hepatic function
- •8. Serum CK/CPK *2.5 ULN
- •9. female participants of childbearing potential and male participants with
- •partners of childbearing potential must use an highly effective method of birth
- •control, as well as their partners, starting at least 1 month prior to the
- •first S64315 administration and lasting at least 30 days after the last dose of
- •10. Women of childbearing potential must have been tested negative in a serum
- •pregnancy test within 7 days prior to the first day of test drug administration.
- •11. Written informed consent prior any study-specific procedure
排除标准
- •12. Unlikely to cooperate in the study.
- •13. Participant already enrolled in the study who has received at least one
- •S64315 infusion.
- •14. Pregnancy, breastfeeding or possibility of becoming pregnant during the
- •15. Participation in another interventional study requiring investigational
- •treatment intake within 2 weeks or at least 5 half-lives (whichever is longer)
- •prior to first dose of S64315 (participation in non-interventional registries
- •or epidemiological studies is allowed).
- •16. Presence of * CTCAE grade 2 toxicity (except alopecia of any grade) due to
- •prior cancer therapy, according to NCI-CTCAE, version 4.03
- •17. Known carriers of HIV antibodies,
- •18. Known history of significant liver disease,
- •19. Uncontrolled hepatitis B or C infection,
- •20. Known active or chronic pancreatitis,
- •21. History of myocardial infarction (MI), angina pectoris, coronary artery
- •bypass graft (CABG) within 6 months prior to starting study treatment,
- •22. Clinically significant cardiac arrhythmias, complete left bundle branch
- •block, high-grade AV block
- •23. Troponin (I/T) > ULN,
- •24. LVEF < 50% as assessed by echocardiogram (ECHO) or Multi-Gated Acquisition
- •scan (MUGA scan),
- •25. QTc prolongation defined as a QTc interval (corrected with Fredericia) >
- •450 ms for male and > 470 ms for female,
- •26. Clinically active severe skin diseases,
- •27. Any clinically significant medical condition or laboratory abnormality
- •likely to jeopardize the patient*s safety or to interfere with the conduct of
- •the study, in the investigator*s opinion,
- •28. Active central nervous system disease,
- •29. Unresolved diarrhea CTCAE grade 2 or higher or presence of medical
- •condition associated with chronical diarrhea (such as irritable bowel syndrome,
- •inflammatory bowel disease)
- •30. Patients with coagulopathy that will increase the risk of bleeding
- •complications according to investigator*s judgment
- •31. Allogenic stem cell transplant within 3 months before the first dose of
- •S64315 and for patients who still receive immunosuppressive treatment,
- •32. Major surgery (involving a risk to the life of the patient) within 2 weeks
- •before the first dose of S64315, or patients who have not recovered from side
- •effects of the surgery,
- •33. Any previous anti-neoplastic treatment for the studied disease at least 5
- •half-lives of this treatment prior to first dose of S64315 (except for
- •hydroxycarbamide),
- •34. Malignant disease, other than that being treated in this study. Exceptions
- •to this exclusion include the following: malignancies that were treated
- •curatively and have not recurred within 2 years prior to study entry;
- •completely resected basal cell and squamous cell skin cancers; any malignancy
- •considered to be indolent and that has never required therapy; and completely
- •resected carcinoma in situ of any type,
- •35. Any radiotherapy within 2 weeks before the first dose of S64315 (except for
- •palliative radiotherapy at localised lesions),
- •36. Prior treatment with an Mcl-1 inhibitor,
- 另有 6 项未显示
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