Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT02598570

Collaborator

Infinity Pharmaceuticals, Inc. (Industry)

Enrollment

Locations

Arm

Actual Duration (Months)

2.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: duvelisib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: duvelisib Duvelisib will be administered orally as a fixed dose in 28-day cycles.	Drug: duvelisib Duvelisib will be administered orally as a fixed dose in 28-day cycles. Other Names: IPI-145 ABBV-954

Arm

Intervention/Treatment

Experimental: duvelisib

Duvelisib will be administered orally as a fixed dose in 28-day cycles.

Drug: duvelisib

Duvelisib will be administered orally as a fixed dose in 28-day cycles.

Other Names:

IPI-145

ABBV-954

Outcome Measures

Primary Outcome Measures

Number of participants reporting Treatment-emergent Adverse Events [Throughout the study for approximately 2 years]
The number of participants reporting treatment-emergent adverse events.
Maximum Observed Plasma Concentration (Cmax) of Duvelisib [Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5]
Time to Maximum Observed Concentration (Tmax) of Duvelisib [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 [Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5]

Secondary Outcome Measures

Overall Response Rate [Throughout the study for approximately 2 years]
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 [Throughout the study for approximately 2 years]
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 [Throughout the study for approximately 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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