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: Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
- Official Title: A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)
Clinical Trial IDs
- ORG STUDY ID:
ME-401-003
- SECONDARY ID:
2018-002896-17
- NCT ID:
NCT03768505
Conditions
- Follicular Lymphoma (FL)
- Non Hodgkin Lymphoma
- Marginal Zone Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Zandelisib (ME-401) | | Zandelisib (ME-401) open label |
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
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Zandelisib (ME-401) open label | Experimental | Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS). | |
Eligibility Criteria
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
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 or refractory FL or MZL 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
April 8, 2021