A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

Incyte logo

Incyte

Status and phase

Completed
Phase 1

Conditions

Lymphoma

Treatments

Drug: Parsaclisib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03314922
Parsaclisib (Other Identifier)
INCB 50465-111/CITADEL-111

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell lymphoma.

Enrollment

17 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • First generation Japanese; subject was born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry.
  • Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
  • Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
  • Willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Life expectancy > 3 months.
  • Eastern Cooperative Oncology Group performance status of 0 to 2.
  • Adequate hematologic, hepatic, and renal function.

Exclusion criteria

  • Evidence of transformed non-Hodgkin's lymphoma histologies.
  • Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
  • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
  • Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
  • Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug.
  • Active graft-versus-host disease.
  • History of stroke or intracranial hemorrhage within 6 months of study drug administration.
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of the date of the first dose of study drug.
  • Known human immunodeficiency virus infection.
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Parsaclisib
Experimental group
Treatment:
Drug: Parsaclisib

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems