Clinical Trials /

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

NCT03768505

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

Related Conditions:
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
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

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

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