Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
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|ClinicalTrials.gov Identifier: NCT03768505|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : January 13, 2023
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma (FL) Non Hodgkin Lymphoma Marginal Zone Lymphoma||Drug: Zandelisib (ME-401)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||April 2025|
Experimental: Zandelisib (ME-401) open label
Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).
Drug: Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg
- 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 ]ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
- Duration of response (DOR) [ Time Frame: 2 years ]Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
- Complete response (CR) rate [ Time Frame: 2 years ]Complete response rate will be measured by the number of subjects that achieve CR
- Progression-free survival (PFS) [ Time Frame: 2 years ]Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
- Overall Survival [ Time Frame: 2 years ]Overall survival will be measured as the time from initiation of treatment (Day 1) until death
- Overall incidence of treatment emergent adverse events (TEAEs) [ Time Frame: 2 years ]The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
- PK of ME-401 [ Time Frame: 6 months ]The PK of ME-401 will be determined by the peak plasma concentration (Cmax)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768505