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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 : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
MEI Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE December 15, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • To evaluate the objective response rate (ORR) of ME-401 in relapsed FL, defined as the best response rating of complete response (CR) or partial response (PR) [ Time Frame: 2 years ]
    ORR is measured according to the Lugano Response Criteria (Cheson 2014), as determined by an Independent Response Review Committee (IRRC)
  • To evaluate the tolerability of ME-401, defined as the rate of AEs requiring modified dosing schedule or study drug discontinuation (AERDM) [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • To evaluate the efficacy of ME-401 as assessed by an Independent Response Review Committee (IRRC): Duration of response (DOR) among subjects with an objective response [ Time Frame: 2 years ]
  • To evaluate the efficacy of ME-401 as assessed by an Independent Response Review Committee (IRRC): Complete response (CR) rate [ Time Frame: 2 years ]
  • To evaluate the efficacy of ME-401 as assessed by an Independent Response Review Committee (IRRC): Progression-free survival (PFS) [ Time Frame: 2 years ]
  • To evaluate the efficacy of ME-401 as assessed by the Investigator: Objective response rate (ORR) [ Time Frame: 2 years ]
  • To evaluate the efficacy of ME-401 as assessed by the Investigator: Duration of response (DOR) among subjects with an objective response [ Time Frame: 2 years ]
  • To evaluate the efficacy of ME-401 as assessed by the Investigator: Complete response (CR) rate [ Time Frame: 2 years ]
  • To evaluate the efficacy of ME-401 as assessed by the Investigator: Progression-free survival (PFS) [ Time Frame: 2 years ]
  • To evaluate the overall survival (OS) [ Time Frame: 2 years ]
    Overall survival
  • To evaluate the safety profile of ME-401: Overall incidence of AEs [ Time Frame: 2 years ]
  • To evaluate the safety profile of ME-401: Time to occurrence of AERDM [ Time Frame: 2 years ]
  • To evaluate the PK of ME-401 [ Time Frame: 6 months ]
    To evaluate ME-401 PK by obtaining plasma samples
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Official Title  ICMJE 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)
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
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)
Primary Purpose: Treatment
Condition  ICMJE
  • Follicular Lymphoma (FL)
  • Non Hodgkin Lymphoma
  • Marginal Zone Lymphoma
Intervention  ICMJE Drug: Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg
Study Arms  ICMJE 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).
Intervention: Drug: Zandelisib (ME-401)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2020)
180
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
165
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MEI Pharma MEI Pharma 858-369-7100 Patients@meipharma.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   France,   Germany,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03768505
Other Study ID Numbers  ICMJE ME-401-003
2018-002896-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MEI Pharma, Inc.
Study Sponsor  ICMJE MEI Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MEI Pharma, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP