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)
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- STATUS
- Recruiting
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- End date
- Sep 30, 2024
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- participants needed
- 200
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- sponsor
- Incyte Corporation
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 Identifier | NCT04509700 |
| Sponsor | Incyte Corporation |
| Last Modified on | 22 October 2022 |
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