A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Purpose

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Condition

  • Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men and women, aged 18 years or older. - Documented failure to achieve at least partial response (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 phosphatidylinositol 3-kinase delta (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: Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Treatment A (Exposed to Ibrutinib) 		Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465
Experimental
Cohort 1: Treatment B (Exposed to Ibrutinib) 		Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465
Experimental
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) 		Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465
Experimental
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) 		Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
  • Drug: Parsaclisib
    Parsaclisib tablets administered orally with water and without regard to food.
    Other names:
    • INCB050465

More Details

Status
Active, not recruiting
Sponsor
Incyte Corporation

Study Contact