Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

Phase 1

Completed

• Conditions: Lymphoma
• Interventions: Drug: duvelisib

• Registration Number: NCT02598570
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-21
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Primary Completion: 2016-12
• Status Verified: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
duvelisib	duvelisib	Duvelisib will be administered orally as a fixed dose in 28-day cycles.

Primary Outcome Measures

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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (3)

Site Reference ID/Investigator# 141595; 🇯🇵 Fukuoka, Japan

Site Reference ID/Investigator# 141826; 🇯🇵 Aichi, Japan

Site Reference ID/Investigator# 141594; 🇯🇵 Tokyo, Japan