An open-label study of INCB050465 in patients with relapsed or refractory Marginal Zone Lymphoma with or without prior exposure to a BTK inhibitor.

Phase 1

Conditions: Marginal Zone Lymphoma
MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-000970-12-ES

Lead Sponsor: Incyte Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

- Men and women, aged 18 or older
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures > 1.5 cm in the longest transverse diameter (LDi) and = 1.0 cm in the longest perpendicular diameter as assessed by CT or magnetic resonance imaging (MRI).
-Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
- Subjects must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

Exclusion Criteria

- Evidence of diffuse large B-cell transformation.
- History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- Prior treatment with idelalisib, other selective PI3Kd 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 the 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with marginal zone lymphoma that is relapsed or refractory after at least 1 systemic treatment regimen.;Secondary Objective: - To assess duration of response (DOR).<br>- To assess complete response rate (CRR).<br>- To assess progression-free survival (PFS).<br>- To assess overall survival (OS).<br>- To assess the best percentage change in target lesion size.<br>- To characterize the safety and tolerability of INCB050465.;Primary end point(s): ORR defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by Independent Review Committee (IRC) assessment of response according to computed tomography (CT)-based response criteria for lymphomas.;Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome Measures

Name	Time	Method

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