Description:
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
Title
- Brief Title: ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
- Official Title: A Multicenter, Open Label Single-Arm, Phase 2 Study of ME-401 in Subjects With Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies
Clinical Trial IDs
- ORG STUDY ID:
ME-401-003
- SECONDARY ID:
2018-002896-17
- NCT ID:
NCT03768505
Conditions
- Follicular Lymphoma (FL)
- Non Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
ME-401 | | ME-401 open label |
Purpose
This is the study of the PI3Kδ inhibitor ME-401 in subjects with relapsed/refractory
follicular lymphoma after failure of at least 2 prior lines of systemic therapy
Detailed Description
This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor
ME-401 in subjects with relapsed/refractory follicular 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 120 subjects will be enrolled and treated with ME-401 on the intermittent
schedule.
Trial Arms
Name | Type | Description | Interventions |
---|
ME-401 open label | Experimental | Subjects with relapsed/refractory FL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS). | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of follicular lymphoma (FL) as defined in the World
Health Organization (WHO) classification scheme, limited to Grade 1, 2, or 3a
- Subjects that have had progression of disease or had no response to therapy after at
least 2 prior systemic therapies for FL
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) of ME-401 in relapsed FL based on the Independent Review Committee assessment |
Time Frame: | 2 years |
Safety Issue: | |
Description: | ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD |
Secondary Outcome Measures
Measure: | Duration of response (DOR) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression |
Measure: | Complete response (CR) rate |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Complete response rate will be measured by the number of subjects that achieve CR |
Measure: | Progression-free survival (PFS) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death |
Measure: | Overall Survival |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Overall survival will be measured as the time from initiation of treatment (Day 1) until death |
Measure: | Overall incidence of treatment emergent adverse events (TEAEs) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE. |
Measure: | PK of ME-401 |
Time Frame: | 6 months |
Safety Issue: | |
Description: | The PK of ME-401 will be determined by the peak plasma concentration (Cmax) |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | MEI Pharma, Inc. |
Last Updated
February 6, 2020