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-PL
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-13
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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.
-Subjects with splenic MZL who do not have a tumor to biopsy or archival tumor tissue are eligible for participation provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained since completion of last therapy and within two years before the date of the first dose of study treatment.
• 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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified