Clinical Trials /

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

NCT03768505

Description:

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

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
ME-401ME-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

NameTypeDescriptionInterventions
ME-401 open labelExperimentalSubjects with relapsed/refractory FL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
  • ME-401

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