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: 20.0 Level: PT Classification code 10076596 Term: Marginal zone lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000970-12-FR
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-12
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• 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