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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03768505
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
MEI Pharma, Inc.

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

Condition or disease Intervention/treatment Phase
Follicular Lymphoma (FL) Non Hodgkin Lymphoma Marginal Zone Lymphoma Drug: Zandelisib (ME-401) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
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 : December 15, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2025


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Complete response (CR) rate [ Time Frame: 2 years ]
    Complete response rate will be measured by the number of subjects that achieve CR

  3. 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

  4. Overall Survival [ Time Frame: 2 years ]
    Overall survival will be measured as the time from initiation of treatment (Day 1) until death

  5. 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.

  6. PK of ME-401 [ Time Frame: 6 months ]
    The PK of ME-401 will be determined by the peak plasma concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: MEI Pharma MEI Pharma 858-369-7100 Patients@meipharma.com

Locations
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Sponsors and Collaborators
MEI Pharma, Inc.
Additional Information:
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Responsible Party: MEI Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03768505    
Other Study ID Numbers: ME-401-003
2018-002896-17 ( EudraCT Number )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell