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Completed

NCT Number: NCT02598570

Study Evaluating 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.

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Key information

Conditions

Lymphoma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemic and Lymphatic Diseases Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 141826, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duvelisib

Drug

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

Other names: IPI-145, ABBV-954

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Infinity Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 6, 2015
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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