Clinical Trials Directory

Trials / Completed

CompletedNCT03235544

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
162 (actual)
Sponsor
Incyte Corporation · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Conditions

Interventions

TypeNameDescription
DRUGParsaclisibParsaclisib tablets administered orally with water and without regard to food.

Timeline

Start date
2017-11-20
Primary completion
2024-04-30
Completion
2024-04-30
First posted
2017-08-01
Last updated
2025-03-18
Results posted
2022-02-10

Locations

103 sites across 11 countries: United States, Belgium, Czechia, Denmark, France, Germany, Israel, Italy, Poland, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03235544. Inclusion in this directory is not an endorsement.

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyros (NCT03235544) · Clinical Trials Directory