NCT02598570

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1 lymphoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

October 21, 2015

Last Update Submit

February 3, 2017

Conditions

Lymphoma

Keywords

Relapsed LymphomaPhosphoinositide 3-kinase (PI3K) InhibitorDuvelisibJapaneseRefractory Lymphoma

Outcome Measures

Primary Outcomes (4)

  • Number of participants reporting Treatment-emergent Adverse Events

    The number of participants reporting treatment-emergent adverse events.

    Throughout the study for approximately 2 years

  • Maximum Observed Plasma Concentration (Cmax) of Duvelisib

    Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5

  • 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 Outcomes (3)

  • Overall Response Rate

    Throughout the study for approximately 2 years

  • Overall Survival

    Throughout the study for approximately 2 years

  • Progression Free Survival

    Throughout the study for approximately 2 years

Study Arms (1)

duvelisib

EXPERIMENTAL

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

Drug: duvelisib

Interventions

duvelisibDRUG

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

Also known as: IPI-145, ABBV-954
duvelisib

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site Reference ID/Investigator# 141826

Aichi, Japan

Location

Site Reference ID/Investigator# 141595

Fukuoka, Japan

Location

Site Reference ID/Investigator# 141594

Tokyo, Japan

Location

MeSH Terms

Conditions

LymphomaHereditary Sensory and Autonomic Neuropathies

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

November 6, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

February 6, 2017

Record last verified: 2017-02

Locations

JP(3)