Clinical trial NCT03768505: Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Follicular Lymphoma (FL)
Non Hodgkin Lymphoma
Marginal Zone Lymphoma
Lead sponsor: MEI Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL
timeFrame: 3 years 9 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: 3 years 9 months
measure: Complete Response (CR) Rate
timeFrame: 3 years 9 months
measure: Progression-free Survival (PFS)
timeFrame: 3 years 9 months
measure: Overall Survival
timeFrame: 2 years
measure: Overall Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: 3 years 9 months
measure: PK of ME-401
timeFrame: 3 years 9 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Oncology Institute of Hope and Innovation
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology
state: California
city: Downey
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Tampa
country: United States
facility: H. Lee Moffit Cancer Center
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic-Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Niles
country: United States
facility: Advocate Health & Hospitals Corporation
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana LLC
state: Indiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Henderson
country: United States
facility: The Oncology Institute of Hope and Innovation
state: Nevada
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology
state: New Mexico
city: Commack
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Renovatio Clinical
state: Texas
city: Edmonds
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates PS
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center
state: Wisconsin
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: West Perth
country: Australia
facility: The Perth Blood Institute
state: Western Australia
city: Sydney
country: Australia
facility: Liverpool Hospital
city: Linz
country: Austria
facility: Kepler Universitatsklinikum GmBH
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Bayonne
country: France
facility: C H de la Cote Basque, Service d'Hematologie
city: La Roche-Sur-Yon Cedex 9
country: France
facility: CHD Vendee, Onco-hematologie
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Trier
country: Germany
facility: Klinikum Mutterhaus Feldstr
state: Rheinland-Pfalz
city: Nordheim
country: Germany
facility: Hamatologisch-Onkolgische Praxis
state: Stolberg
city: Halle
country: Germany
facility: Universitatsklinikum Halle
city: Munich
country: Germany
facility: Munich Municipal Hospital
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Genova
country: Italy
facility: IRCCS AOU Policlinico San Martino
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
city: Napoli
country: Italy
facility: UOC Oncoematologia
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Rimini
country: Italy
facility: Infermi Hospital Rimini
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: Rome
country: Italy
facility: IRCCS Regina Elena National Cancer Institute
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
city: Venice
country: Italy
facility: Ospedale DellAngelo Di Mestre Umberto I
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea-Seoul St. Marys Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Dunedin
country: New Zealand
facility: Southern District Hospital
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.
city: Kraków
country: Poland
facility: Pratia MCM Krakow
city: Warszawa
country: Poland
facility: Primary Specialty Oncology
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
city: Łódź
country: Poland
facility: ojewodzkie Wielospecjalistyczne Centrum
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Mutua Terrasa
city: Barcelona
country: Spain
facility: ICO-Hospital Duran i Reynals
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario Quiron Salud Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Salamanca
country: Spain
facility: Hospital Clinico de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Zaragoza
country: Spain
facility: Miguel Servet Hospital
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliero Cantonale (EOC)
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center, Liouying
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital NTUH
city: Rhyl
country: United Kingdom
facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital
state: Denbighire
city: London
country: United Kingdom
facility: Royal Marsden Hospital
state: Sutton
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
state: UK
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust - Belfast City Hospital
city: Cornwell
country: United Kingdom
facility: Royal Cornwall Hospital
city: Liverpool
country: United Kingdom
facility: e Clatterbridge Cancer Centre
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Lewisham and Greenwich University Hospital Lewisham
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Centre for Haematology, Imperial College London
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
References: