Moffitt logo

Clinical Trials Search

Clinical Trial 19584

Cancer Type: Malignant Hematology
Interventions:INCB050465; Not Applicable

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Bijal Shah

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kä Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

Summary

Objective

To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with mantle cell lymphoma (MCL) that is relapsed or refractory after at least 1 but no more than 3 prior systemic treatment regimens.

Inclusion Criteria

  • Men and women, aged 18 years or older (except in South Korea, aged 19 or older).
  • Documented failure to achieve at least PR with, or documented disease progression after, the most recent treatment regimen.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

  • Exclusion Criteria

  • History of central nervous system lymphoma (either primary or metastatic).
  • Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan 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 first dose of study treatment.
  • Active graft-versus-host disease.
  • Liver disease: Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti-hepatitis B core antibody.