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The study is designed as a single-center,open-label,phase 1 dose-escalation study to assess the safety,tolerability,pharmacokinetics, and anti-tumor efficacy of OPB-31121 in patients with relapsed or refractory NHL or MM.
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Inclusion criteria
Exclusion criteria
Patients are receiving another investigational agent or who have received another investigational agent within 6 months.
Patients are receiving concurrent chemotherapy, biologic agents, or radiotherapy.
Patients are receiving concurrent administration of warfarin.
NHL or MM patients who are candidates for autologous stem cell transplantation are excluded from the study.
Patients with other primary malignancy except squamous or basal cell skin cancer or cervical cancer in situ.
Patients with acute lymphoblastic lymphoma/leukaemia, POEMS syndrome or plasma cell leukaemia.
Lymphoma patients with symptomatic CNS involvement.
Patients with uncontrolled intercurrent illness.
Known HIV-positive/AIDS patients.
Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period.
Patients will not or are unable to use appropriate contraceptive methods during the study period and for at least 6 months after completion of the study
Patients need to receive any of the following treatments or therapeutic agents during the study period:
Primary purpose
Allocation
Interventional model
Masking
42 participants in 1 patient group
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Central trial contact
Shii Man, M.D & Ph.D.
Data sourced from clinicaltrials.gov
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