Clinical Trials /

Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

NCT04509700

Description:

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib to participants from Incyte-sponsored studies of parsaclisib.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04509700

Trial Eligibility

Document

Title

  • Brief Title: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
  • Official Title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Clinical Trial IDs

  • ORG STUDY ID: INCB 50465-801
  • NCT ID: NCT04509700

Conditions

  • B-Cell Malignancies

Interventions

DrugSynonymsArms
ParsaclisibINCB050465parsaclisib
parsaclisib + itacitinibINCB050465, INCB39110parsaclicib + itacitinib

Purpose

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib to participants from Incyte-sponsored studies of parsaclisib.

Detailed Description

      The purpose of this study is to provide continued use of parsaclisib as monotherapy or in
      combination with itacitinib to participants who are currently enrolled in an Incyte-sponsored
      study and receiving the same treatment, who have at least stable disease, who are obtaining
      clinical benefit (in the opinion of the investigator) on the current study treatment, as
      defined by the parent Protocol, and who are unable to access parsaclisib as monotherapy or in
      combination with itacitinib outside a clinical study.Participants will continue on the same
      dose and schedule as the ones being administered in the Incyte-sponsored parent Protocol at
      the time of the rollover. The study will collect and assess safety information with regards
      to AEs.

Trial Arms

NameTypeDescriptionInterventions
parsaclisibExperimentalParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.
  • Parsaclisib
parsaclicib + itacitinibExperimentalParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.
  • parsaclisib + itacitinib

Eligibility Criteria

        Inclusion Criteria:

          -  Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of
             parsaclisib.

          -  Currently tolerating treatment in the parent Protocol.

          -  Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or
             in combination therapy with itacitinib, as determined by the investigator.

          -  Has at least stable disease, as determined by the investigator.

          -  Has demonstrated compliance, as assessed by the investigator, with the parent Protocol
             requirements.

          -  Willingness and ability to comply with scheduled visits, treatment plans, including
             PJP prophylaxis, and any other study procedures indicated in this Protocol.

          -  Willingness to avoid pregnancy or fathering children

          -  Ability to comprehend and willingness to sign an ICF

        Exclusion Criteria:

          -  Has been permanently discontinued from study treatment in the parent Protocol for any
             reason.

          -  Able to access parsaclisib as monotherapy or in combination with itacitinib therapy
             outside a clinical study.

          -  Participants with an uncontrolled intercurrent illness or any concurrent condition
             that, in the investigator's opinion, would jeopardize the safety of the participant or
             compliance with the Protocol.

          -  Pregnant or breastfeeding women.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame:Through study completion, an average of 5 years
Safety Issue:
Description:Number of participants with treatment-related AEs

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • non-Hodgkin lymphoma
  • phosphatidylinositol 3-kinase
  • myeloproliferative neoplasm

Last Updated

August 4, 2021