Back to results

Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

duvelisib

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Site Reference ID/Investigator# 141826
Site Reference ID/Investigator# 141595
Site Reference ID/Investigator# 141594

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

duvelisib

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants reporting Treatment-emergent Adverse Events

The number of participants reporting treatment-emergent adverse events.

Maximum Observed Plasma Concentration (Cmax) of Duvelisib

Time to Maximum Observed Concentration (Tmax) of Duvelisib

Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT02598570

First Posted

October 21, 2015

Last Updated

February 3, 2017

Sponsor

AbbVie

Collaborators

Infinity Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02598570

Brief Title

Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

November 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

Collaborators

Infinity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

duvelisib

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

duvelisib

Other Intervention Name(s)

IPI-145, ABBV-954

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants reporting Treatment-emergent Adverse Events

Description

The number of participants reporting treatment-emergent adverse events.

Time Frame

Throughout the study for approximately 2 years

Title

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

Title

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

Title

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 Outcome Measure Information:

Title

Overall Response Rate

Description

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.

Time Frame

Throughout the study for approximately 2 years

Title

Overall Survival

Description

Overall survival is defined as the duration in weeks from the date of the first dose of study treatment until the date of death.

Time Frame

Throughout the study for approximately 2 years

Title

Progression Free Survival

Description

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.

Time Frame

Throughout the study for approximately 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Site Reference ID/Investigator# 141826

City

Aichi

Country

Japan

Facility Name

Site Reference ID/Investigator# 141595

City

Fukuoka

Country

Japan

Facility Name

Site Reference ID/Investigator# 141594

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

We'll reach out to this number within 24 hrs