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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03768505
Other study ID # ME-401-003
Secondary ID 2018-002896-17
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 25, 2019
Est. completion date March 24, 2023

Study information

Verified date December 2022
Source MEI Pharma, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 169
Est. completion date March 24, 2023
Est. primary completion date March 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg

Locations

Country Name City State
Australia Peninsula and South Eastern Haematology and Oncology Group Frankston Victoria
Australia Liverpool Hospital Sydney
Australia The Perth Blood Institute West Perth Western Australia
Austria Kepler Universitatsklinikum GmBH Linz
Austria Medical University of Vienna Vienna
Belgium AZ Sint-Jan Brugge-Oostende Brugge
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Institut Jules Bordet Brussels
Belgium Antwerp University Hospital Edegem
France C H de la Cote Basque, Service d'Hematologie Bayonne
France CHD Vendee, Onco-hematologie La Roche-Sur-Yon Cedex 9
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
Germany Universitatsklinikum Halle Halle
Germany Munich Municipal Hospital Munich
Germany Universitatsklinikum Munster Münster
Germany Hamatologisch-Onkolgische Praxis Nordheim Stolberg
Germany Klinikum Mutterhaus Feldstr Trier Rheinland-Pfalz
Germany Universitatsklinikum Ulm Ulm
Italy 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
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea-Seoul St. Marys Hospital Seoul
Korea, Republic of Ulsan University Hospital Ulsan
New Zealand North Shore Hospital Auckland
New Zealand Southern District Hospital Dunedin
Poland Szpital Uniwersytecki nr 2 im. Bydgoszcz
Poland Pratia MCM Krakow Kraków
Poland ojewodzkie Wielospecjalistyczne Centrum Lódz
Poland Instytut Hematologii i Transfuzjologii Warszawa
Poland Primary Specialty Oncology Warszawa
Poland Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku Wroclaw
Spain Hospital Universitari Mutua Terrasa Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain ICO-Hospital Duran i Reynals Barcelona
Spain Hospital Universitario de Canarias La Laguna Tenerife
Spain Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario Quiron Salud Madrid Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain MD Anderson Cancer Center Madrid
Spain Complejo Hospitalario de Navarra Pamplona
Spain Hospital Clinico de Salamanca Salamanca
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Virgen del Rocio Sevilla
Spain Miguel Servet Hospital Zaragoza
Switzerland Ente Ospedaliero Cantonale (EOC) Bellinzona
Taiwan China Medical University Hospital Taichung
Taiwan Chi-Mei Medical Center, Liouying Tainan
Taiwan National Cheng Kung University Hospital Tainan City
Taiwan National Taiwan University Hospital NTUH Taipei City
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 Centre for Haematology, Imperial College London London
United Kingdom Lewisham and Greenwich University Hospital Lewisham London
United Kingdom Royal Marsden Hospital London Sutton
United Kingdom St George's Hospital London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Norfolk and Norwich University Hospital NHS Foundation Trust Norwich
United Kingdom Nottingham University Hospital Nottingham UK
United Kingdom Oxford University Hospitals Oxford
United Kingdom North Wales Cancer Treatment Centre, Glan Clwyd Hospital Rhyl Denbighire
United Kingdom Royal Hallamshire Hospital Sheffield
United States Pacific Cancer Medical Center, Inc. Anaheim California
United States University of Michigan Medical School Ann Arbor Michigan
United States Memorial Sloan Kettering Basking Ridge New Jersey
United States Tower Hematology Oncology Beverly Hills California
United States St. Vincent Frontier Cancer Center Billings Montana
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Rush University Medical Center Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Memorial Sloan Kettering Commack New York
United States The Oncology Institute of Hope and Innovation Downey California
United States Duke Cancer Center Durham North Carolina
United States Swedish Cancer Institute Edmonds Washington
United States San Juan Oncology Farmington New Mexico
United States Memorial Sloan Kettering Harrison New York
United States The Oncology Institute of Hope and Innovation Henderson Nevada
United States Renovatio Clinical Houston Texas
United States Investigative Clinical Research of Indiana LLC Indianapolis Indiana
United States Clinical Research Alliance Lake Success New York
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Marshfield Medical Center Marshfield Wisconsin
United States Memorial Sloan Kettering Middletown New Jersey
United States Memorial Sloan Kettering Montvale New Jersey
United States Vanderbilt University Nashville Tennessee
United States Memorial Sloan Kettering New York New York
United States Advocate Health & Hospitals Corporation Niles Illinois
United States Oregon Health and Science University Portland Oregon
United States Sharp Memorial Hospital San Diego California
United States Swedish Cancer Institute Seattle Washington
United States Medical Oncology Associates PS Spokane Washington
United States Stony Brook University Stony Brook New York
United States H. Lee Moffit Cancer Center Tampa Florida
United States Oncology Institute of Hope and Innovation Tucson Arizona
United States Memorial Sloan Kettering Uniondale New York
United States Cleveland Clinic-Florida Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
MEI Pharma, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  France,  Germany,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD 3 years 9 months
Secondary Duration of Response (DOR) Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression 3 years 9 months
Secondary Complete Response (CR) Rate Complete response rate will be measured by the number of subjects that achieve CR 3 years 9 months
Secondary Progression-free Survival (PFS) Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death 3 years 9 months
Secondary Overall Survival Overall survival will be measured as the time from initiation of treatment (Day 1) until death 2 years
Secondary Overall Incidence of Treatment Emergent Adverse Events (TEAEs) The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE. 3 years 9 months
Secondary PK of ME-401 The PK of ME-401 will be determined by the peak plasma concentration (Cmax) 3 years 9 months
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