Overview

This trial is active, not recruiting.

Condition lymphoma
Treatment duvelisib
Phase phase 1
Sponsor AbbVie
Collaborator Infinity Pharmaceuticals, Inc.
Start date November 2015
End date December 2016
Trial size 6 participants
Trial identifier NCT02598570, M15-460

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Duvelisib will be administered orally as a fixed dose in 28-day cycles.
duvelisib IPI-145
Duvelisib will be administered orally as a fixed dose in 28-day cycles.

Primary Outcomes

Measure
Number of participants reporting Treatment-emergent Adverse Events
time frame: Throughout the study for approximately 2 years
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 99 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AbbVie.