A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
- Conditions
- Advanced malignanciesMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0Level: PTClassification code 10003899Term: B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2019-004948-30-DK
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
* 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
* 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable