Non-Hodgkin's Lymphoma(NHL)Phase 1NCT00511082
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
A Phase 1 study testing OPB-31121 in people with Non-Hodgkin's Lymphoma(NHL) and Multiple Myeloma, run by Otsuka Beijing Research Institute at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma(NHL), Multiple Myeloma
- What is being tested?
- OPB-31121
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteHong Kong
- Study dates
- Dec 2007to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
- 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
Read the detailed description
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.
- Conditions
- Non-Hodgkin's Lymphoma(NHL), Multiple Myeloma
- Being tested
- OPB-31121
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-31121Drug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: OPB-31121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 4 weeks
Secondary outcomes (1)
1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's Lymphoma(NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Kenny IK Lei, M.D, Principal investigator, Department of Clinical Oncology, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511082
- Sponsor's protocol ID
- 252-07-801-01
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2007
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00511082
- Acronym / sponsor ID
- 252-07-801-01
- Conditions
- Non-Hodgkin's Lymphoma(NHL), Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2007 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: OPB-31121Investigational 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPB-31121100-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 | Drug | Treatment group |
Primary outcome
Safety and tolerability
Time frame: 4 weeks
1 secondary outcome
1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenny IK Lei, M.D principal investigator
Department of Clinical Oncology, Prince of Wales Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPB-31121 in people with Non-Hodgkin's Lymphoma(NHL) and Multiple Myeloma, run by Otsuka Beijing Research Institute at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.