Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
NCT ID: NCT03768505
Last Updated: 2024-12-31
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
169 participants
INTERVENTIONAL
2019-06-25
2023-03-24
Brief Summary
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Detailed Description
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Approximately 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg
Interventions
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Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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MEI Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Oncology Institute of Hope and Innovation
Tucson, Arizona, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Tower Hematology Oncology
Beverly Hills, California, United States
The Oncology Institute of Hope and Innovation
Downey, California, United States
Sharp Memorial Hospital
San Diego, California, United States
H. Lee Moffit Cancer Center
Tampa, Florida, United States
Cleveland Clinic-Florida
Weston, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Health & Hospitals Corporation
Niles, Illinois, United States
Investigative Clinical Research of Indiana LLC
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Medical School
Ann Arbor, Michigan, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
The Oncology Institute of Hope and Innovation
Henderson, Nevada, United States
Memorial Sloan Kettering
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering
Middletown, New Jersey, United States
Memorial Sloan Kettering
Montvale, New Jersey, United States
San Juan Oncology
Farmington, New Mexico, United States
Memorial Sloan Kettering
Commack, New York, United States
Memorial Sloan Kettering
Harrison, New York, United States
Clinical Research Alliance
Lake Success, New York, United States
Memorial Sloan Kettering
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Memorial Sloan Kettering
Uniondale, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Vanderbilt University
Nashville, Tennessee, United States
Renovatio Clinical
Houston, Texas, United States
Swedish Cancer Institute
Edmonds, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Medical Oncology Associates PS
Spokane, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Marshfield Medical Center
Marshfield, Wisconsin, United States
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
The Perth Blood Institute
West Perth, Western Australia, Australia
Liverpool Hospital
Sydney, , Australia
Kepler Universitatsklinikum GmBH
Linz, , Austria
Medical University of Vienna
Vienna, , Austria
AZ Sint-Jan Brugge-Oostende
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Antwerp University Hospital
Edegem, , Belgium
C H de la Cote Basque, Service d'Hematologie
Bayonne, , France
CHD Vendee, Onco-hematologie
La Roche-sur-Yon, , France
Centre Hospitalier du Mans
Le Mans, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
Poitiers, , France
Institut Gustave Roussy
Villejuif, , France
Klinikum Mutterhaus Feldstr
Trier, Rhineland-Palatinate, Germany
Hamatologisch-Onkolgische Praxis
Nordheim, Stolberg, Germany
Universitatsklinikum Halle
Halle, , Germany
Munich Municipal Hospital
Munich, , Germany
Universitatsklinikum Munster
Münster, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano, , Italy
Policlinico Sant'Orsola Malpighi
Bologna, , Italy
IRCCS AOU Policlinico San Martino
Genova, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
Meldola, , Italy
UOC Oncoematologia
Napoli, , Italy
Ospedale Santa Maria delle Croci
Ravenna, , Italy
Infermi Hospital Rimini
Rimini, , Italy
Universita Cattolica del Sacro Cuore
Roma, , Italy
IRCCS Regina Elena National Cancer Institute
Rome, , Italy
Azienda Ospedaliera Santa Maria
Terni, , Italy
Ospedale DellAngelo Di Mestre Umberto I
Venice, , Italy
North Shore Hospital
Auckland, , New Zealand
Southern District Hospital
Dunedin, , New Zealand
Szpital Uniwersytecki nr 2 im.
Bydgoszcz, , Poland
Pratia MCM Krakow
Krakow, , Poland
ojewodzkie Wielospecjalistyczne Centrum
Lodz, , Poland
Primary Specialty Oncology
Warsaw, , Poland
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, , Poland
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
The Catholic University of Korea-Seoul St. Marys Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitari Mutua Terrasa
Barcelona, , Spain
ICO-Hospital Duran i Reynals
Barcelona, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Quiron Salud Madrid
Madrid, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Clinico de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Miguel Servet Hospital
Zaragoza, , Spain
Ente Ospedaliero Cantonale (EOC)
Bellinzona, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chi-Mei Medical Center, Liouying
Tainan City, , Taiwan
National Taiwan University Hospital NTUH
Taipei, , Taiwan
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, Denbighire, United Kingdom
Royal Marsden Hospital
London, Sutton, United Kingdom
Nottingham University Hospital
Nottingham, UK, United Kingdom
Belfast Health and Social Care Trust - Belfast City Hospital
Belfast, , United Kingdom
Royal Cornwall Hospital
Cornwell, , United Kingdom
e Clatterbridge Cancer Centre
Liverpool, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Lewisham and Greenwich University Hospital Lewisham
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Centre for Haematology, Imperial College London
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, , United Kingdom
Oxford University Hospitals
Oxford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002896-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ME-401-003
Identifier Type: -
Identifier Source: org_study_id