Advanced malignancies MedDRA version: 20.0 Level: PT Classification code 10003899 Term: B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: parsaclisib 20 mg Tablets
Product Code: INCB050465 20 mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: PARSACLISIB
CAS Number: 1426698-88-5
Current Sponsor code: INCB050465
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Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib. * Adult male and female participants with B-cell malignancies; * Currently enrolled in a parent Protocol of parsaclisib 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, 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 Pneumocystis jiroveci pneumonia prophylaxis, and any other studyprocedures indicated in this Protocol. * Willingness to avoid pregnancy or fathering children based on criteria in Protocol Section 5.1. * Ability to comprehend and willingness to sign an ICF. NB: the parent Protocol is defined as the study that the participant is rolling over from Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 175
Exclusion criteria
Exclusion criteria: * Has been permanently discontinued from study treatment in the parent Protocol for any reason. * Able to access parsaclisib as monotherapy 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide continued treatment and evaluation of safety in participants receiving parsaclisib (INCB050465) as monotherapy.;Secondary Objective: none;Primary end point(s): To assess AEs and SAEs reported in participants receiving parsaclisib as monotherapy or in combination therapy with itacitinib.;Timepoint(s) of evaluation of this end point: throughout the study and at least every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Incyte Corporation
Outcome results
None listed