Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
duvelisib
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Presence of active systemic infection within 72 hours of treatment
- Human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
Sites / Locations
- Site Reference ID/Investigator# 141826
- Site Reference ID/Investigator# 141595
- Site Reference ID/Investigator# 141594
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
duvelisib
Arm Description
Duvelisib will be administered orally as a fixed dose in 28-day cycles.
Outcomes
Primary Outcome Measures
Number of participants reporting Treatment-emergent Adverse Events
The number of participants reporting treatment-emergent adverse events.
Maximum Observed Plasma Concentration (Cmax) of Duvelisib
Time to Maximum Observed Concentration (Tmax) of Duvelisib
Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02598570
First Posted
October 21, 2015
Last Updated
February 3, 2017
Sponsor
AbbVie
Collaborators
Infinity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02598570
Brief Title
Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Infinity Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
duvelisib
Arm Type
Experimental
Arm Description
Duvelisib will be administered orally as a fixed dose in 28-day cycles.
Intervention Type
Drug
Intervention Name(s)
duvelisib
Other Intervention Name(s)
IPI-145, ABBV-954
Intervention Description
Duvelisib will be administered orally as a fixed dose in 28-day cycles.
Primary Outcome Measure Information:
Title
Number of participants reporting Treatment-emergent Adverse Events
Description
The number of participants reporting treatment-emergent adverse events.
Time Frame
Throughout the study for approximately 2 years
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
Throughout the study for approximately 2 years
Title
Overall Survival
Description
Overall survival is defined as the duration in weeks from the date of the first dose of study treatment until the date of death.
Time Frame
Throughout the study for approximately 2 years
Title
Progression Free Survival
Description
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.
Time Frame
Throughout the study for approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Presence of active systemic infection within 72 hours of treatment
Human immunodeficiency virus (HIV) infection
Pregnant or lactating women
Facility Information:
Facility Name
Site Reference ID/Investigator# 141826
City
Aichi
Country
Japan
Facility Name
Site Reference ID/Investigator# 141595
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 141594
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
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