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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Investigational Medicinal Product: OPB-31121 25-mg tablet, 100-mg tablet Dose: OPB-31121 50, 100, 200, 400, 600, 800, and 1000 mg Dosage regimen: ingestion with water after breakfast Treatment period: 4 weeks Mode of Administration: oral administration of OPB-31121 once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPB-31121 | Drug | 100-mg tablet Dose: OPB-31121 50, 100, 200, 400, 600, 800, and 1000 mg Dosage regimen: ingestion with water after breakfast Treatment period: 4 weeks Mode of Administration: oral administration of OPB-31121 once daily |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria | 4 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Kenny IK Lei, M.D | Department of Clinical Oncology, Prince of Wales Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |