BridgeMD
A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Parsaclisib (INCB050465)
EU CTIS ID: 2022-501687-18-00
What this study is testing
To provide continued treatment and evaluation of safety in participants receiving parsaclisib (INCB050465) as monotherapy or in combination therapy with itacitinib (INCB039110), ruxolitinib (INCB018424), or ibrutinib., or tafasitamab (INCMOR00208; including participants who remain on tafasitamab alone).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
- Israel
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey; Israel; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.