An open-label study of INCB050465 in patients with relapsed or refractory Marginal Zone Lymphoma with or without prior exposure to a BTK inhibitor.
- Conditions
- Marginal Zone LymphomaMedDRA version: 20.0Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000970-12-IT
- Lead Sponsor
- INCYTE CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
• 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 an archival tumor tissue sample 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 2 years before the date of the first dose of study treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Full list of inclusion criteria is described in section 3.1 of Protocol
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
• 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
Full list of exclusion criteria is described in section 3.2 of Protocol
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<br>tomography (CT)-based response criteria for lymphomas;Timepoint(s) of evaluation of this end point: Throughout the study
- Secondary Outcome Measures
Name Time Method