Clinical trial · Interventional
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
NCT00511082CI-TRIAL-00088574completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin's Lymphoma(NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPB-31121 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- 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
- interventionNames
- Drug: OPB-31121
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- 4 weeks
Secondary outcomes (1)
- measure
- 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.