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

Registration Number
NCT04509700
Lead Sponsor
Incyte Corporation
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
112
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
parsaclisibParsaclisibParticipants 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.
parsaclicib + itacitinibparsaclisib + itacitinibParticipants 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 + ibrutinibparsaclisib + ibrutinibParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover.
parsaclisib + ruxolitinibparsaclisib + ruxolitinibParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover.
Primary Outcome Measures
NameTimeMethod
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]Through study completion, an average of 5 years

Number of participants with treatment-related AEs

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (104)

Uab Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

University of Alabama At Birmingham

🇺🇸

Birmingham, Alabama, United States

Mayo Clinic Rochester

🇺🇸

Phoenix, Arizona, United States

University of Arizona Cancer Center-Out Pt.

🇺🇸

Tucson, Arizona, United States

City of Hope National Medical Center

🇺🇸

Duarte, California, United States

California Cancer Associates For Research and Excellence

🇺🇸

Fresno, California, United States

Innovative Clinical Research Institute

🇺🇸

Long Beach, California, United States

Rocky Mountain Cancer Center

🇺🇸

Aurora, Colorado, United States

Rush University Medical Center-Consultants in Hematology

🇺🇸

Chicago, Illinois, United States

University of Kansas Hospital Authority

🇺🇸

Westwood, Kansas, United States

Scroll for more (94 remaining)
Uab Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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