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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)



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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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United States, Arizona
Oncology Institute of Hope and Innovation Recruiting
Tucson, Arizona, United States, 85710
United States, California
Pacific Cancer Medical Center, Inc. Recruiting
Anaheim, California, United States, 92801
The Oncology Institute of Hope and Innovation Recruiting
Downey, California, United States, 90241
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
United States, Florida
H. Lee Moffit Cancer Center Recruiting
Tampa, Florida, United States, 33612
Cleveland Clinic-Florida Recruiting
Weston, Florida, United States, 333331
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Advocate Health & Hospitals Corporation Recruiting
Niles, Illinois, United States, 61761
United States, Indiana
Investigative Clinical Research of Indiana LLC Recruiting
Indianapolis, Indiana, United States, 46260
United States, Michigan
University of Michigan Medical School Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Montana
St. Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59102
United States, Nevada
The Oncology Institute of Hope and Innovation Recruiting
Henderson, Nevada, United States, 89052
United States, New Jersey
Memorial Sloan Kettering Recruiting
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Recruiting
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Recruiting
Montvale, New Jersey, United States, 07645
United States, New Mexico
San Juan Oncology Recruiting
Farmington, New Mexico, United States, 87401
United States, New York
Memorial Sloan Kettering Recruiting
Commack, New York, United States, 11725
Memorial Sloan Kettering Recruiting
Harrison, New York, United States, 10604
Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10065
Stony Brook University Withdrawn
Stony Brook, New York, United States, 11794
Memorial Sloan Kettering Recruiting
Uniondale, New York, United States, 11553
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Renovatio Clinical Recruiting
Houston, Texas, United States, 77056
United States, Washington
Swedish Cancer Institute Recruiting
Edmonds, Washington, United States, 98026
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Medical Oncology Associates PS Recruiting
Spokane, Washington, United States, 99208
Northwest Medical Specialties Withdrawn
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53705
Marshfield Medical Center Recruiting
Marshfield, Wisconsin, United States, 54449
Australia, Victoria
Peninsula and South Eastern Haematology and Oncology Group Recruiting
Frankston, Victoria, Australia, 3199
Australia, Western Australia
The Perth Blood Institute Recruiting
West Perth, Western Australia, Australia, 6005
Australia
Liverpool Hospital Recruiting
Sydney, Australia, NSW2170
Austria
Kepler Universitatsklinikum GmBH Recruiting
Linz, Austria, 4021
Medical University of Vienna Recruiting
Vienna, Austria, 1160
Belgium
AZ Sint-Jan Brugge-Oostende Recruiting
Brugge, Belgium, 8000
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Antwerp University Hospital Recruiting
Edegem, Belgium, 2650
France
C H de la Cote Basque, Service d'Hematologie Recruiting
Bayonne, France, 64100
CHD Vendee, Onco-hematologie Recruiting
La Roche-Sur-Yon Cedex 9, France, 85925
Centre Hospitalier du Mans Recruiting
Le Mans, France, F720000
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France, 68100
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie Recruiting
Poitiers, France, 86021
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Germany
Hamatologisch-Onkolgische Praxis Recruiting
Nordheim, Stolberg, Germany, 52222
Universitatsklinikum Halle Recruiting
Halle, Germany, 06120
Italy
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS Recruiting
Aviano, Italy, 33081
Policlinico Sant'Orsola Malpighi Recruiting
Bologna, Italy, 40138
IRCCS AOU Policlinico San Martino Recruiting
Genova, Italy, 16132
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T. Recruiting
Meldola, Italy, 47014
Ospedale Santa Maria delle Croci Recruiting
Ravenna, Italy, 48121
Infermi Hospital Rimini Recruiting
Rimini, Italy, 47923
Universita Cattolica del Sacro Cuore Recruiting
Roma, Italy, 00168
IRCCS Regina Elena National Cancer Institute Recruiting
Rome, Italy, 00144
Ospedale DellAngelo Di Mestre Umberto I Recruiting
Venice, Italy, 30174
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Contact       Patients@meipharma.com   
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact       Patients@meipharma.com   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 07985
The Catholic University of Korea-Seoul St. Marys Hospital Recruiting
Seoul, Korea, Republic of, 6591
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 44033
New Zealand
North Shore Hospital Recruiting
Auckland, New Zealand, 0622
Contact: Leo Gonzales-Perez    64 9 486 8920 ext 43702    Leo.Gonzalez-Perez@waitematadhb.govt.nz   
Contact: Nuria Lopez Rozain       Nuria.LopezRosain@waitematadhb.govt.nz   
Southern District Hospital Recruiting
Dunedin, New Zealand, 9054
Contact: Tracey Steiner    64 (0)3 4740999 ext 59941    tracey.steiner@southerndhb.govt.nz   
Contact: Karen Eden    64 (0)3 470 9986    Karen.Eden@southerndhb.govt.nz   
Poland
Szpital Uniwersytecki nr 2 im. Recruiting
Bydgoszcz, Poland, 85-168
Pratia MCM Krakow Recruiting
Kraków, Poland, 30-510
Contact       Patients@meipharma.com   
Primary Specialty Oncology Recruiting
Warszawa, Poland, 02-034
Instytut Hematologii i Transfuzjologii Recruiting
Warszawa, Poland, 02-776
ojewodzkie Wielospecjalistyczne Centrum Recruiting
Łódź, Poland, 93-510
Spain
Hospital Universitario de Canarias Recruiting
La Laguna, Tenerife, Spain, 38320
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Universitari Mutua Terrasa Recruiting
Barcelona, Spain, 08221
ICO-Hospital Duran i Reynals Recruiting
Barcelona, Spain, 08908
MD Anderson Cancer Center Recruiting
Madrid, Spain, 28033
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario Quiron Salud Madrid Recruiting
Madrid, Spain, 28223
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain, 31008
Hospital Clinico de Salamanca Recruiting
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Miguel Servet Hospital Recruiting
Zaragoza, Spain, 50009
Switzerland
Ente Ospedaliero Cantonale (EOC) Recruiting
Bellinzona, Switzerland, 6500
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Chi-Mei Medical Center, Liouying Recruiting
Tainan, Taiwan, 736
National Taiwan University Hospital NTUH Recruiting
Taipei City, Taiwan, 10002
United Kingdom
North Wales Cancer Treatment Centre, Glan Clwyd Hospital Recruiting
Rhyl, Denbighire, United Kingdom, LL185UJ
Royal Marsden Hospital Recruiting
London, Sutton, United Kingdom, SM25PT
Nottingham University Hospital Recruiting
Nottingham, UK, United Kingdom, NG51PB
Belfast Health and Social Care Trust - Belfast City Hospital Recruiting
Belfast, United Kingdom, 28040
Royal Cornwall Hospital Recruiting
Cornwell, United Kingdom, TR1 3LJ
e Clatterbridge Cancer Centre Recruiting
Liverpool, United Kingdom, L78XP
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L78XP
Lewisham and Greenwich University Hospital Lewisham Recruiting
London, United Kingdom, SE136LH
St George's Hospital Recruiting
London, United Kingdom, SW170QT
Centre for Haematology, Imperial College London Recruiting
London, United Kingdom, W12ONN
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20
Norfolk and Norwich University Hospital NHS Foundation Trust Recruiting
Norwich, United Kingdom, NR4 7UY
Oxford University Hospitals Recruiting
Oxford, United Kingdom, 0X46LB
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S102JF
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