Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: parsaclisib Participants 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. |
Drug: Parsaclisib
Participants 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.
Other Names:
|
Experimental: parsaclicib + itacitinib Participants 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. |
Drug: parsaclisib + itacitinib
Participants 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.
Other Names:
|
Experimental: parsaclisib + ruxolitinib Participants 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. |
Drug: parsaclisib + ruxolitinib
Participants 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.
Other Names:
|
Experimental: parsaclisib + ibrutinib Participants 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. |
Drug: parsaclisib + ibrutinib
Participants 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Through study completion, an average of 5 years]
Number of participants with treatment-related AEs
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Uab Comprehensive Cancer Center | Birmingham | Alabama | United States | 35233 |
2 | University of Alabama At Birmingham | Birmingham | Alabama | United States | 35233 |
3 | Mayo Clinic Rochester | Phoenix | Arizona | United States | 85054 |
4 | University of Arizona Cancer Center - Out Pt. | Tucson | Arizona | United States | 85719 |
5 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
6 | California Cancer Associates For Research and Excellence | Fresno | California | United States | 93720 |
7 | University of Kansas Hospital Authority | Westwood | Kansas | United States | 66205 |
8 | Rcca Md, Llc | Bethesda | Maryland | United States | 20817 |
9 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
10 | University of Michigan Cancer Center | Ann Arbor | Michigan | United States | 48109 |
11 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
12 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
13 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
14 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
15 | University Hospitals Case Medical Center | Cleveland | Ohio | United States | 44106 |
16 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
17 | Knight Cancer Institute At Oregon Health and Science University | Portland | Oregon | United States | 97239 |
18 | Texas Oncology-Baylor Charles A. Sammons | Dallas | Texas | United States | 75246 |
19 | Cliniques Universitaires Ucl Saint-Luc | Brussels | Belgium | 01200 | |
20 | The Finsen Centre National Hospital | Copenhagen | Denmark | 02100 | |
21 | Centre Antoine Lacassagne | Nice | France | 06189 | |
22 | Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | 56126 | |
23 | Ospedale Santa Maria Delle Croci | Ravenna | Italy | 48121 | |
24 | Ico Hospital Germans Trias I Pujol | Badalona | Spain | 08916 | |
25 | Hospital Clinic I Provincial | Barcelona | Spain | 08036 | |
26 | Hospital General Universitario Gregorio Maranon | Madrid | Spain | 28009 | |
27 | Hospital Universitario Fundacin Jimnez Daz | Madrid | Spain | 28040 | |
28 | Hospital Universitario Hm Sanchinarro | Madrid | Spain | 28050 | |
29 | Hospital Universitario Virgen Del Rocio | Sevilla | Spain | 41013 |
Sponsors and Collaborators
- Incyte Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INCB 50465-801