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

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04509700
Collaborator
(none)
31
Enrollment
29
Locations
4
Arms
35.2
Anticipated Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

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
  • Drug: Parsaclisib
  • Drug: parsaclisib + itacitinib
  • Drug: parsaclisib + ruxolitinib
  • Drug: parsaclisib + ibrutinib
 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

Study Type:
Interventional
Anticipated Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
Actual Study Start Date :
Aug 3, 2020
Anticipated Primary Completion Date :
Jul 10, 2023
Anticipated Study Completion Date :
Jul 10, 2023

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:
  • INCB050465

    		•
    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:
  • INCB050465
  • INCB39110

    		•
    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:
  • INCB050465
  • INCB018424

    		•
    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:
  • INCB050465

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT04509700
    Other Study ID Numbers:
    • INCB 50465-801
    First Posted:
    Aug 12, 2020
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    non-Hodgkin lymphoma
    phosphatidylinositol 3-kinase
    myeloproliferative neoplasm
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jul 27, 2022