A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Parsaclisib (INCB050465)

Phase 1

Recruiting

• Conditions: Advanced malignancies and IAI diseases; MedDRA version: 21.0Level: LLTClassification code: 10048683Term: Advanced cancer Class: 10029104; MedDRA version: 20.0Level: LLTClassification code: 10003825Term: Autoimmune hemolytic anemia Class: 10005329; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501687-18-00
• Lead Sponsor: Incyte Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 177

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 with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone) 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 based on the criteria described in Protocol section 5.1, 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, ibrutinib, or tafasitamab (including tafasitamab alone) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified