Purpose

This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy

Conditions

Eligibility

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

Inclusion Criteria

  • Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme 1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or 2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL - Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL - Age ≥ 18 - At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification - Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment - QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec); - Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria

  • Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma - Known lymphomatous involvement of the central nervous system - Uncontrolled clinically significant illness - Ongoing or history of drug-induced pneumonitis - History of clinically significant cardiovascular abnormalities - History of clinically significant GI conditions - Known history of, or active HIV infection

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Zandelisib (ME-401) open label
Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
  • Drug: Zandelisib (ME-401)
    Zandelisib (ME-401) 60 mg

More Details

Status
Terminated
Sponsor
MEI Pharma, Inc.

Study Contact

Detailed Description

This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. Approximately 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.