We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 2 of 8 for:    ME-401

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03768505
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : January 13, 2023
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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 : June 25, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : April 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Hide Hide 114 study locations
Layout table for location information
United States, Arizona
Oncology Institute of Hope and Innovation
Tucson, Arizona, United States, 85710
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
Tower Hematology Oncology
Beverly Hills, California, United States, 90211
The Oncology Institute of Hope and Innovation
Downey, California, United States, 90241
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Florida
H. Lee Moffit Cancer Center
Tampa, Florida, United States, 33612
Cleveland Clinic-Florida
Weston, Florida, United States, 333331
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Advocate Health & Hospitals Corporation
Niles, Illinois, United States, 61761
United States, Indiana
Investigative Clinical Research of Indiana LLC
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Medical School
Ann Arbor, Michigan, United States, 48109
United States, Montana
St. Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
United States, Nevada
The Oncology Institute of Hope and Innovation
Henderson, Nevada, United States, 89052
United States, New Jersey
Memorial Sloan Kettering
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering
Montvale, New Jersey, United States, 07645
United States, New Mexico
San Juan Oncology
Farmington, New Mexico, United States, 87401
United States, New York
Memorial Sloan Kettering
Commack, New York, United States, 11725
Memorial Sloan Kettering
Harrison, New York, United States, 10604
Clinical Research Alliance
Lake Success, New York, United States, 11042
Memorial Sloan Kettering
New York, New York, United States, 10065
Memorial Sloan Kettering
Uniondale, New York, United States, 11553
United States, North Carolina
Duke Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
United States, Texas
Renovatio Clinical
Houston, Texas, United States, 77056
United States, Washington
Swedish Cancer Institute
Edmonds, Washington, United States, 98026
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Medical Oncology Associates PS
Spokane, Washington, United States, 99208
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Marshfield Medical Center
Marshfield, Wisconsin, United States, 54449
Australia, Victoria
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Australia, Western Australia
The Perth Blood Institute
West Perth, Western Australia, Australia, 6005
Liverpool Hospital
Sydney, Australia, NSW2170
Kepler Universitatsklinikum GmBH
Linz, Austria, 4021
Medical University of Vienna
Vienna, Austria, 1160
AZ Sint-Jan Brugge-Oostende
Brugge, Belgium, 8000
Institut Jules Bordet
Brussels, Belgium, 1000
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Antwerp University Hospital
Edegem, Belgium, 2650
C H de la Cote Basque, Service d'Hematologie
Bayonne, France, 64100
CHD Vendee, Onco-hematologie
La Roche-Sur-Yon Cedex 9, France, 85925
Centre Hospitalier du Mans
Le Mans, France, F720000
Centre Hospitalier de Mulhouse
Mulhouse, France, 68100
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
Poitiers, France, 86021
Institut Gustave Roussy
Villejuif, France, 94805
Klinikum Mutterhaus Feldstr
Trier, Rheinland-Pfalz, Germany
Hamatologisch-Onkolgische Praxis
Nordheim, Stolberg, Germany, 52222
Universitatsklinikum Halle
Halle, Germany, 06120
Munich Municipal Hospital
Munich, Germany, 80804
Universitatsklinikum Munster
Münster, Germany, 48149
Universitatsklinikum Ulm
Ulm, Germany, 89081
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano, Italy, 33081
Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
IRCCS AOU Policlinico San Martino
Genova, Italy, 16132
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
Meldola, Italy, 47014
UOC Oncoematologia
Napoli, Italy, 80131
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Infermi Hospital Rimini
Rimini, Italy, 47923
Universita Cattolica del Sacro Cuore
Roma, Italy, 00168
IRCCS Regina Elena National Cancer Institute
Rome, Italy, 00144
Azienda Ospedaliera Santa Maria
Terni, Italy, 05100
Ospedale DellAngelo Di Mestre Umberto I
Venice, Italy, 30174
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 49201
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 07985
The Catholic University of Korea-Seoul St. Marys Hospital
Seoul, Korea, Republic of, 6591
Ulsan University Hospital
Ulsan, Korea, Republic of, 44033
New Zealand
North Shore Hospital
Auckland, New Zealand, 0622
Southern District Hospital
Dunedin, New Zealand, 9054
Szpital Uniwersytecki nr 2 im.
Bydgoszcz, Poland, 85-168
Pratia MCM Krakow
Kraków, Poland, 30-510
Primary Specialty Oncology
Warszawa, Poland, 02-034
Instytut Hematologii i Transfuzjologii
Warszawa, Poland, 02-776
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, Poland, 53-439
ojewodzkie Wielospecjalistyczne Centrum
Łódź, Poland, 93-510
Hospital Universitario de Canarias
La Laguna, Tenerife, Spain, 38320
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitari Mutua Terrasa
Barcelona, Spain, 08221
ICO-Hospital Duran i Reynals
Barcelona, Spain, 08908
MD Anderson Cancer Center
Madrid, Spain, 28033
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Universitario Quiron Salud Madrid
Madrid, Spain, 28223
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
Hospital Clinico de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Miguel Servet Hospital
Zaragoza, Spain, 50009
Ente Ospedaliero Cantonale (EOC)
Bellinzona, Switzerland, 6500
China Medical University Hospital
Taichung, Taiwan, 40447
National Cheng Kung University Hospital
Tainan City, Taiwan, 70403
Chi-Mei Medical Center, Liouying
Tainan, Taiwan, 736
National Taiwan University Hospital NTUH
Taipei City, Taiwan, 10002
United Kingdom
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, Denbighire, United Kingdom, LL185UJ
Royal Marsden Hospital
London, Sutton, United Kingdom, SM25PT
Nottingham University Hospital
Nottingham, UK, United Kingdom, NG51PB
Belfast Health and Social Care Trust - Belfast City Hospital
Belfast, United Kingdom, 28040
Royal Cornwall Hospital
Cornwell, United Kingdom, TR1 3LJ
e Clatterbridge Cancer Centre
Liverpool, United Kingdom, L78XP
Royal Liverpool University Hospital
Liverpool, United Kingdom, L78XP
Lewisham and Greenwich University Hospital Lewisham
London, United Kingdom, SE136LH
St George's Hospital
London, United Kingdom, SW170QT
Centre for Haematology, Imperial College London
London, United Kingdom, W12ONN
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom, NR4 7UY
Oxford University Hospitals
Oxford, United Kingdom, 0X46LB
Royal Hallamshire Hospital
Sheffield, United Kingdom, S102JF
Sponsors and Collaborators
MEI Pharma, Inc.
Layout table for additonal information
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: January 13, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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