Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

NCT ID: NCT02598570

Last Updated: 2017-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-02-28

Brief Summary

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

Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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duvelisib

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

Group Type EXPERIMENTAL

duvelisib

Intervention Type DRUG

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

Interventions

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duvelisib

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

Intervention Type DRUG

Other Intervention Names

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IPI-145 ABBV-954

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Infinity Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site Reference ID/Investigator# 141826

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 141595

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 141594

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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M15-460

Identifier Type: -

Identifier Source: org_study_id

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