Multiple MyelomaPhase 1NCT01344876
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
A Phase 1 study testing OPB-51602 in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in Japan.
Trial summary
To determine the maximum tolerated dose (MTD) of OPB-51602 Read more about this study
- Who is it for?
- Ages 20 to 75 years, men only
- Conditions the study is for
- Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia
- What is being tested?
- OPB-51602
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesJapan
- Study dates
- Apr 2011to Apr 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
- Patients who are responsive or have relapsed following standard treatment
- Patients capable of providing written informed consent
- Japanese patients age 20 to 75 years (inclusive) at time of informed consent
- ECOG performance status score of 0-1
- Life expectancy of at least 3 months
- Adequate vital organ function
- Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
Who cannot join
- Patients with other primary malignant tumors
- Symptomatic CNS involvement
- Ongoing or active infection, or complication that is not controllable by medication or other means
- Complication of uncontrolled cardiac disease
- Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
- Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
To determine the maximum tolerated dose (MTD) of OPB-51602
- Conditions
- Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia
- Being tested
- OPB-51602
- Keywords
- multiple myeloma [MM], non-Hodgkin lymphoma [NHL], acute myeloid leukemia [AML], acute lymphoid leukemia [ALL], chronic myeloid leukemia [CML]
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-51602Drug
once daily during the treatment period
| Study group | Role | What they receive |
|---|---|---|
| OPB-51602 | Experimental | OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle Receives: Drug: OPB-51602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With Treatment Emergent Adverse Events
Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
Measured: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).
Measured: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Secondary outcomes (1)
Treatment Response
Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, chronic myeloid leukemia.
"Response" was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment.
Measured: From first dose of study medication to withdrawal examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344876
- Sponsor's protocol ID
- 266-10-001
- Other IDs
- JapicCTI-111478
- Status last verified
- May 2015
- First submitted
- 26 Apr 2011
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
- ClinicalTrials.gov ID
- NCT01344876
- Acronym / sponsor ID
- 266-10-001
- Conditions
- Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia
- Keywords
- multiple myeloma [MM], non-Hodgkin lymphoma [NHL], acute myeloid leukemia [AML], acute lymphoid leukemia [ALL], chronic myeloid leukemia [CML]
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the maximum tolerated dose (MTD) of OPB-51602
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPB-51602 | Experimental | Drug: OPB-51602OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
- Patients who are responsive or have relapsed following standard treatment
- Patients capable of providing written informed consent
- Japanese patients age 20 to 75 years (inclusive) at time of informed consent
- ECOG performance status score of 0-1
Key exclusion criteria (6 listed)
- Patients with other primary malignant tumors
- Symptomatic CNS involvement
- Ongoing or active infection, or complication that is not controllable by medication or other means
- Complication of uncontrolled cardiac disease
- Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
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-51602once daily during the treatment period | Drug | OPB-51602 |
Primary outcome
Subjects With Treatment Emergent Adverse Events
Time frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).
1 secondary outcome
Treatment Response
Time frame: From first dose of study medication to withdrawal examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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-51602 in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in Japan.
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 8 inclusion and 6 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjects With Treatment Emergent Adverse Events (time frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)). The study lists 2 primary outcomes in all. 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 8 Jun 2015.