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)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    200
  • sponsor
    Incyte Corporation
Updated on 22 October 2022

Summary

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

Description

The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib 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, ruxolitinib, or ibrutinib 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.

Details
Condition B-Cell Malignancies
Treatment Parsaclisib, parsaclisib + itacitinib, parsaclisib + ruxolitinib, parsaclisib + ibrutinib
Clinical Study IdentifierNCT04509700
SponsorIncyte Corporation
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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, ruxolitinib, or ibrutinib 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, ruxolitinib, or ibrutinib 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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