LymphomaPhase 1NCT02598570
Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
A Phase 1 study testing duvelisib in people with Lymphoma, run by AbbVie at 3 sites in Japan.
Trial summary
This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- duvelisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesJapan
- Study dates
- Nov 2015to Feb 2017
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lymphoma (excluding lymphoblastic lymphoma)
- Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy
- Eastern Cooperative Oncology Group (ECOG) performance status lower than or equal to 2
- Life expectancy of at least 3 months
Who cannot join
- Any prior treatment with a PI3K inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
- Ongoing treatment with chronic immune-suppressants
- Overt CNS lymphoma
- Inadequate hepatic, bone marrow, or renal function
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
- Venous thromboembolic event requiring anticoagulation
Show all 9Show fewer
- Presence of active systemic infection within 72 hours of treatment
- Human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Site Reference ID/Investigator# 141826
Aichi
Site Reference ID/Investigator# 141595
Fukuoka
Site Reference ID/Investigator# 141594
Tokyo
About this study
Official title: An Open-Label, Single-Arm, Multicenter Phase 1 Study Evaluating the Safety and Pharmacokinetics of Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.
- Conditions
- Lymphoma
- Being tested
- duvelisib
- Keywords
- Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma
- Medical subject headings
- Lymphoma, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duvelisibDrug
Also called IPI-145, ABBV-954
Duvelisib will be administered orally as a fixed dose in 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| duvelisib | Experimental | Duvelisib will be administered orally as a fixed dose in 28-day cycles. Receives: Drug: duvelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting Treatment-emergent Adverse Events
The number of participants reporting treatment-emergent adverse events.
Measured: Throughout the study for approximately 2 years
Maximum Observed Plasma Concentration (Cmax) of Duvelisib
Measured: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Time to Maximum Observed Concentration (Tmax) of Duvelisib
Measured: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib
Measured: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Secondary outcomes (3)
Overall Response Rate
Overall Response Rate is defined as the proportion of participants with a confirmed response of complete (CR) or partial response (PR) based on the revised International Working Group (IWG) criteria.
Measured: Throughout the study for approximately 2 years
Overall Survival
Overall survival is defined as the duration in weeks from the date of the first dose of study treatment until the date of death.
Measured: Throughout the study for approximately 2 years
Progression Free Survival
Progression free survival is defined as the time from the date of the first dose of study treatment to the first documentation of progressive disease (PD) or death due to any cause.
Measured: Throughout the study for approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Infinity Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598570
- Sponsor's protocol ID
- M15-460
- Status last verified
- Feb 2017
- First submitted
- 21 Oct 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multicenter Phase 1 Study Evaluating the Safety and Pharmacokinetics of Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT02598570
- Acronym / sponsor ID
- M15-460
- Conditions
- Lymphoma
- Keywords
- Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Infinity Pharmaceuticals, Inc.
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Nov 2015 (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.
This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| duvelisib | Experimental | Drug: duvelisibDuvelisib will be administered orally as a fixed dose in 28-day cycles. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of lymphoma (excluding lymphoblastic lymphoma)
- Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy
- Eastern Cooperative Oncology Group (ECOG) performance status lower than or equal to 2
- Life expectancy of at least 3 months
Key exclusion criteria (9 listed)
- Any prior treatment with a PI3K inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
- Ongoing treatment with chronic immune-suppressants
- Overt CNS lymphoma
- Inadequate hepatic, bone marrow, or renal function
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
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 |
|---|---|---|
| duvelisibAlso: IPI-145, ABBV-954Duvelisib will be administered orally as a fixed dose in 28-day cycles. | Drug | duvelisib |
Primary outcome
Number of participants reporting Treatment-emergent Adverse Events
Time frame: Throughout the study for approximately 2 years
The number of participants reporting treatment-emergent adverse events.
Maximum Observed Plasma Concentration (Cmax) of Duvelisib
Time frame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Time to Maximum Observed Concentration (Tmax) of Duvelisib
Time frame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib
Time frame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
3 secondary outcomes
Overall Response Rate
Time frame: Throughout the study for approximately 2 years
Overall Survival
Time frame: Throughout the study for approximately 2 years
Progression Free Survival
Time frame: Throughout the study for approximately 2 years
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 6 Feb 2017.
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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.
3 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 duvelisib in people with Lymphoma, run by AbbVie at 3 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 4 inclusion and 9 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Number of participants reporting Treatment-emergent Adverse Events (time frame: Throughout the study for approximately 2 years). The study lists 4 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 6 Feb 2017.