Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598570
• Other study ID #: M15-460
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2015
• Last updated: February 3, 2017
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• duvelisib
Duvelisib will be administered orally as a fixed dose in 28-day cycles.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 141826	Aichi
Japan	Site Reference ID/Investigator# 141595	Fukuoka
Japan	Site Reference ID/Investigator# 141594	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Infinity Pharmaceuticals, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

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