A dose-escalation trial to investigate the safety and tolerability of OPB-51602 in patients with relapsed or refractory hematologic malignancies (Phase 1)

Otsuka Pharmaceutical Co., Ltd.0 个研究点开始时间: 2011年4月25日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
•2) Patients who are responsive or have relapsed following standard treatment
•3) Patients capable of providing written informed consent
•4) Japanese patients age 20 to 75 years (inclusive) at time of informed consent
•5) ECOG performance status score of 0-1
•6) Life expectancy of at least 3 months
•7) Adequate vital organ function
•8) Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration

•1) Patients with other primary malignant tumors
•2) Symptomatic CNS involvement
•3) Ongoing or active infection, or complication that is not controllable by medication or other means
•4) Complication of uncontrolled cardiac disease
•5) Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
•6) Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment

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