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JOURNAL ONKOLOGIE – STUDIE

Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

Rekrutierend

NCT-Nummer:
NCT03768505

Studienbeginn:
Dezember 2018

Letztes Update:
09.02.2021

Wirkstoff:
Zandelisib (ME-401)

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
MEI Pharma, Inc.

Collaborator:
-

Kontakt

Studienlocations (3 von 115)

Klinikum Mutterhaus Feldstr
Trier
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Hamatologisch-Onkolgische Praxis
52222 Nordheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Halle
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Munich Municipal Hospital
80804 Munich
(Bayern)
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Universitatsklinikum Munster
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Ulm
89081 Ulm
(Baden-Württemberg)
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Oncology Institute of Hope and Innovation
85710 Tucson
United StatesRekrutierend» Google-Maps
Pacific Cancer Medical Center, Inc.
92801 Anaheim
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Tower Hematology Oncology
90211 Beverly Hills
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The Oncology Institute of Hope and Innovation
90241 Downey
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Sharp Memorial Hospital
92123 San Diego
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H. Lee Moffit Cancer Center
33612 Tampa
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Cleveland Clinic-Florida
333331 Weston
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Rush University Medical Center
60612 Chicago
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Advocate Health & Hospitals Corporation
61761 Niles
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Investigative Clinical Research of Indiana LLC
46260 Indianapolis
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Dana-Farber Cancer Institute
02215 Boston
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University of Michigan Medical School
48109 Ann Arbor
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St. Vincent Frontier Cancer Center
59102 Billings
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The Oncology Institute of Hope and Innovation
89052 Henderson
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Memorial Sloan Kettering
07920 Basking Ridge
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Memorial Sloan Kettering
07748 Middletown
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Memorial Sloan Kettering
07645 Montvale
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Memorial Sloan Kettering
11725 Commack
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Memorial Sloan Kettering
10604 Harrison
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Clinical Research Alliance
11042 Lake Success
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Memorial Sloan Kettering
10065 New York
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Stony Brook University
11794 Stony Brook
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Memorial Sloan Kettering
11553 Uniondale
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Oregon Health and Science University
97239 Portland
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Vanderbilt University
37203 Nashville
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Swedish Cancer Institute
98026 Edmonds
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Swedish Cancer Institute
98104 Seattle
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Medical Oncology Associates PS
99208 Spokane
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Northwest Medical Specialties
98405 Tacoma
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University of Wisconsin Carbone Cancer Center
53705 Madison
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Marshfield Medical Center
54449 Marshfield
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Peninsula and South Eastern Haematology and Oncology Group
3199 Frankston
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The Perth Blood Institute
6005 West Perth
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Kepler Universitatsklinikum GmBH
4021 Linz
AustriaRekrutierend» Google-Maps
Cliniques Universitaires Saint-Luc
1200 Brussels
BelgiumRekrutierend» Google-Maps
C H de la Cote Basque, Service d'Hematologie
64100 Bayonne
FranceRekrutierend» Google-Maps
CHD Vendee, Onco-hematologie
85925 La Roche-Sur-Yon Cedex 9
FranceRekrutierend» Google-Maps
Centre Hospitalier de Mulhouse
68100 Mulhouse
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Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie
86021 Poitiers
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Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
33081 Aviano
ItalyRekrutierend» Google-Maps
Policlinico Sant'Orsola Malpighi
40138 Bologna
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IRCCS AOU Policlinico San Martino
16132 Genova
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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.
47014 Meldola
ItalyRekrutierend» Google-Maps
Ospedale Santa Maria delle Croci
48121 Ravenna
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Universita Cattolica del Sacro Cuore
00168 Roma
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IRCCS Regina Elena National Cancer Institute
00144 Rome
ItalyRekrutierend» Google-Maps
Ospedale DellAngelo Di Mestre Umberto I
30174 Venice
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Pusan National University Hospital
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
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Seoul National University Hospital
03080 Seoul
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Samsung Medical Center
06351 Seoul
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Ewha Womans University Mokdong Hospital
07985 Seoul
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The Catholic University of Korea-Seoul St. Marys Hospital
6591 Seoul
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Ulsan University Hospital
44033 Ulsan
Korea, Republic ofRekrutierend» Google-Maps
North Shore Hospital
0622 Auckland
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Ansprechpartner:
Leo Gonzales-Perez
Phone: 64 9 486 8920 ext 43702
E-Mail: Leo.Gonzalez-Perez@waitematadhb.govt.nz

Nuria Lopez Rozain
E-Mail: Nuria.LopezRosain@waitematadhb.govt.nz
» Ansprechpartner anzeigen
Southern District Hospital
9054 Dunedin
New ZealandRekrutierend» Google-Maps
Ansprechpartner:
Tracey Steiner
Phone: 64 (0)3 4740999 ext 59941
E-Mail: tracey.steiner@southerndhb.govt.nz

Karen Eden
Phone: 64 (0)3 470 9986
E-Mail: Karen.Eden@southerndhb.govt.nz
» Ansprechpartner anzeigen
Szpital Uniwersytecki nr 2 im.
85-168 Bydgoszcz
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Instytut Hematologii i Transfuzjologii
02-776 Warszawa
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ojewodzkie Wielospecjalistyczne Centrum
93-510 Łódź
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Hospital Universitario de Canarias
38320 La Laguna
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Hospital Universitari Vall d'Hebron
08035 Barcelona
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Hospital Universitari Mutua Terrasa
08221 Barcelona
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ICO-Hospital Duran i Reynals
08908 Barcelona
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Hospital Universitario Ramon y Cajal
28034 Madrid
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Hospital Universitario Quiron Salud Madrid
28223 Madrid
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Complejo Hospitalario de Navarra
31008 Pamplona
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Hospital Clinico de Salamanca
37007 Salamanca
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Hospital Universitario Virgen Macarena
41009 Sevilla
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Ente Ospedaliero Cantonale (EOC)
6500 Bellinzona
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China Medical University Hospital
40447 Taichung
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National Cheng Kung University Hospital
70403 Tainan City
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Chi-Mei Medical Center, Liouying
736 Tainan
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National Taiwan University Hospital NTUH
10002 Taipei City
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North Wales Cancer Treatment Centre, Glan Clwyd Hospital
LL185UJ Rhyl
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Royal Marsden Hospital
SM25PT London
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Nottingham University Hospital
NG51PB Nottingham
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Belfast Health and Social Care Trust - Belfast City Hospital
28040 Belfast
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Royal Cornwall Hospital
TR1 3LJ Cornwell
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e Clatterbridge Cancer Centre
L78XP Liverpool
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Royal Liverpool University Hospital
L78XP Liverpool
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Lewisham and Greenwich University Hospital Lewisham
SE136LH London
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St George's Hospital
SW170QT London
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Centre for Haematology, Imperial College London
W12ONN London
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The Christie NHS Foundation Trust
M20 Manchester
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Norfolk and Norwich University Hospital NHS Foundation Trust
NR4 7UY Norwich
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Oxford University Hospitals
0X46LB Oxford
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Royal Hallamshire Hospital
S102JF Sheffield
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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)

Studien-Arme

  • Experimental: Group A, Continuous schedule
    ME-401 administered daily continuously, in a capsule, taken orally
  • Experimental: Group B, Intermittent schedule
    ME-401 administered daily continuously for 2 cycles then daily for the first 7 days of each subsequent cycle, in a capsule, taken orally

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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