WHO ICTRP trial

A multicenter, open-label, randomized study comparing INCB050465 to idelalisib…

EUCTR2017-001624-22-ES · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2017-001624-22-ES
Public title A multicenter, open-label, randomized study comparing INCB050465 to idelalisib in patients with relapsed or refractory follicular lymphoma
Scientific title A Phase 2, Multicenter, Open-Label, Randomized Study Comparing INCB050465, a PI3Kd Inhibitor, to Idelalisib in Relapsed or Refractory Follicular Lymphoma - CITADEL-203
Primary sponsor Incyte Corporation
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Spain;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Australia;Denmark;Germany;Sweden
Conditions Follicular Lymphoma MedDRA version: 20.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Product Code: INCB050465 1 mg tablet Pharmaceutical Form: Tablet INN or Proposed INN: not yet assigned Current Sponsor code: INCB050465 Other descriptive name: INCB050465 HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type…
Registration date Jan 12, 2017
Target size 180
Secondary IDs INCB50465-203;NCT03126019;2017-001624-22-HU
Registry page clinicaltrialsregister.eu

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