Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

MEI Pharma

Status and phase: Terminated; Phase 2

Conditions: Marginal Zone Lymphoma; Follicular Lymphoma (FL); Non Hodgkin Lymphoma

Treatments: Drug: Zandelisib (ME-401)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03768505

2018-002896-17 (EudraCT Number)

ME-401-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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169 participants in 1 patient group

Zandelisib (ME-401) open label

Experimental group

Description:

Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).

Treatment:

Drug: Zandelisib (ME-401)