Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

February 3, 2017 updated by: AbbVie

An Open-Label, Single-Arm, Multicenter Phase 1 Study Evaluating the Safety and Pharmacokinetics of Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Site Reference ID/Investigator# 141826
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 141595
      • Tokyo, Japan
        • Site Reference ID/Investigator# 141594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants reporting Treatment-emergent Adverse Events
Time Frame: Throughout the study for approximately 2 years
The number of participants reporting treatment-emergent adverse events.
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
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
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
Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 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.
Throughout the study for approximately 2 years
Overall Survival
Time Frame: 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.
Throughout the study for approximately 2 years
Progression Free Survival
Time Frame: 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.
Throughout the study for approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Infinity Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-460

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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