Multiple Myeloma(MM) Clinical Trial
Official title:
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
- To investigate the safety and tolerability of OPB-31121 following repeated oral
administration of OPB-31121 in patients Non-Hodgkin's Lymphoma(NHL) or Multiple
Myeloma(MM)
- To determine the potential dose-limiting toxicities and maximum-tolerated dose in
patients treated with OPB-31121
- To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients
| Status | Unknown status |
| Enrollment | 42 |
| Est. completion date | December 2009 |
| Est. primary completion date | September 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients must have relapsed or refractory NHL histologically confirmed. - Relapsed or refractory NHL or MM patients must have experienced treatment failure. - Chinese patients aged 18 years or older at the time of giving informed consent. - Performance status score of 0-2 according to the incriteria of he Eastern Cooperative Oncology Group(ECOG) - Life expectancy of longer than 3 months. - Patients must have adequate vital organ function. - Patients are willing to comply with the visit schedules of the hospitalization and outpatient clinic. - Patients with prior chemotherapy, immunotherapy, cytokines therapy, major surgery, and radiotherapy to the index lesion must have been completed for a minimum period of 4 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration. - Patients with systemic corticosteroid therapy (>10 mg prednisone or equivalent) must have been completed for a minimum of 1 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration. - Patients with prior stem cell transplantation must be at least 8 weeks and have recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration. 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: - Anti-cancer drugs other than the study drug - Systemic corticosteroid therapy (>10 mg prednisone or equivalent) - Radiotherapy as primary therapy - Immunotherapy - Surgical therapy - CYP3A4 and CYP2C9 enzyme inducers or inhibitors,or substrates, and CYP2B6, CYP2C8, and CYP2D6 substrates. |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Department of Clinical Oncology, Prince of Wales Hospital | Shatin, N.T. | Hong Kong, SAR |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Beijing Research Institute | Otsuka Pharmaceutical Co., Ltd. |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and tolerability | 4 weeks | ||
| Secondary | 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria | 4 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05439538 -
Serum NGAL IN Patients With Multiple Myeloma
|