Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Study Details
Study Description
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 |
---|---|---|
|
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.
Study Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) of ME-401 in relapsed or refractory FL or MZL based on the Independent Review Committee assessment [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
- Duration of response (DOR) [2 years]
Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
- Complete response (CR) rate [2 years]
Complete response rate will be measured by the number of subjects that achieve CR
- Progression-free survival (PFS) [2 years]
Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
- Overall Survival [2 years]
Overall survival will be measured as the time from initiation of treatment (Day 1) until death
- Overall incidence of treatment emergent adverse events (TEAEs) [2 years]
The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
- PK of ME-401 [6 months]
The PK of ME-401 will be determined by the peak plasma concentration (Cmax)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme
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Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or
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Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL
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Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL
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Age ≥ 18
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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
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Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
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QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (msec);
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Left ventricular ejection fraction (LVEF) ≥ 45%
Exclusion Criteria:
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Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
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Known lymphomatous involvement of the central nervous system
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Uncontrolled clinically significant illness
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Ongoing or history of drug-induced pneumonitis
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History of clinically significant cardiovascular abnormalities
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History of clinically significant GI conditions
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Known history of, or active HIV infection
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Oncology Institute of Hope and Innovation | Tucson | Arizona | United States | 85710 |
2 | Pacific Cancer Medical Center, Inc. | Anaheim | California | United States | 92801 |
3 | Tower Hematology Oncology | Beverly Hills | California | United States | 90211 |
4 | The Oncology Institute of Hope and Innovation | Downey | California | United States | 90241 |
5 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
6 | H. Lee Moffit Cancer Center | Tampa | Florida | United States | 33612 |
7 | Cleveland Clinic-Florida | Weston | Florida | United States | 333331 |
8 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
9 | Advocate Health & Hospitals Corporation | Niles | Illinois | United States | 61761 |
10 | Investigative Clinical Research of Indiana LLC | Indianapolis | Indiana | United States | 46260 |
11 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
12 | University of Michigan Medical School | Ann Arbor | Michigan | United States | 48109 |
13 | St. Vincent Frontier Cancer Center | Billings | Montana | United States | 59102 |
14 | The Oncology Institute of Hope and Innovation | Henderson | Nevada | United States | 89052 |
15 | Memorial Sloan Kettering | Basking Ridge | New Jersey | United States | 07920 |
16 | Memorial Sloan Kettering | Middletown | New Jersey | United States | 07748 |
17 | Memorial Sloan Kettering | Montvale | New Jersey | United States | 07645 |
18 | San Juan Oncology | Farmington | New Mexico | United States | 87401 |
19 | Memorial Sloan Kettering | Commack | New York | United States | 11725 |
20 | Memorial Sloan Kettering | Harrison | New York | United States | 10604 |
21 | Clinical Research Alliance | Lake Success | New York | United States | 11042 |
22 | Memorial Sloan Kettering | New York | New York | United States | 10065 |
23 | Stony Brook University | Stony Brook | New York | United States | 11794 |
24 | Memorial Sloan Kettering | Uniondale | New York | United States | 11553 |
25 | Duke Cancer Center | Durham | North Carolina | United States | 27710 |
26 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
27 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
28 | Vanderbilt University | Nashville | Tennessee | United States | 37203 |
29 | Renovatio Clinical | Houston | Texas | United States | 77056 |
30 | Swedish Cancer Institute | Edmonds | Washington | United States | 98026 |
31 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
32 | Medical Oncology Associates PS | Spokane | Washington | United States | 99208 |
33 | Northwest Medical Specialties | Tacoma | Washington | United States | 98405 |
34 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53705 |
35 | Marshfield Medical Center | Marshfield | Wisconsin | United States | 54449 |
36 | Peninsula and South Eastern Haematology and Oncology Group | Frankston | Victoria | Australia | 3199 |
37 | The Perth Blood Institute | West Perth | Western Australia | Australia | 6005 |
38 | Liverpool Hospital | Sydney | Australia | NSW2170 | |
39 | Kepler Universitatsklinikum GmBH | Linz | Austria | 4021 | |
40 | Medical University of Vienna | Vienna | Austria | 1160 | |
41 | AZ Sint-Jan Brugge-Oostende | Brugge | Belgium | 8000 | |
42 | Institut Jules Bordet | Brussels | Belgium | 1000 | |
43 | Cliniques Universitaires Saint-Luc | Brussels | Belgium | 1200 | |
44 | Antwerp University Hospital | Edegem | Belgium | 2650 | |
45 | C H de la Cote Basque, Service d'Hematologie | Bayonne | France | 64100 | |
46 | CHD Vendee, Onco-hematologie | La Roche-Sur-Yon Cedex 9 | France | 85925 | |
47 | Centre Hospitalier du Mans | Le Mans | France | F720000 | |
48 | Centre Hospitalier de Mulhouse | Mulhouse | France | 68100 | |
49 | Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie | Poitiers | France | 86021 | |
50 | Institut Gustave Roussy | Villejuif | France | 94805 | |
51 | Klinikum Mutterhaus Feldstr | Trier | Rheinland-Pfalz | Germany | |
52 | Hamatologisch-Onkolgische Praxis | Nordheim | Stolberg | Germany | 52222 |
53 | Universitatsklinikum Halle | Halle | Germany | 06120 | |
54 | Munich Municipal Hospital | Munich | Germany | 80804 | |
55 | Universitatsklinikum Munster | Münster | Germany | 48149 | |
56 | Universitatsklinikum Ulm | Ulm | Germany | 89081 | |
57 | Centro di Riferimento Oncologico di Aviano (CRO) IRCCS | Aviano | Italy | 33081 | |
58 | Policlinico Sant'Orsola Malpighi | Bologna | Italy | 40138 | |
59 | IRCCS AOU Policlinico San Martino | Genova | Italy | 16132 | |
60 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T. | Meldola | Italy | 47014 | |
61 | UOC Oncoematologia | Napoli | Italy | 80131 | |
62 | Ospedale Santa Maria delle Croci | Ravenna | Italy | 48121 | |
63 | Infermi Hospital Rimini | Rimini | Italy | 47923 | |
64 | Universita Cattolica del Sacro Cuore | Roma | Italy | 00168 | |
65 | IRCCS Regina Elena National Cancer Institute | Rome | Italy | 00144 | |
66 | Azienda Ospedaliera Santa Maria | Terni | Italy | 05100 | |
67 | Ospedale DellAngelo Di Mestre Umberto I | Venice | Italy | 30174 | |
68 | Dong-A University Hospital | Busan | Korea, Republic of | 49201 | |
69 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
70 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
71 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
72 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
73 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
74 | Ewha Womans University Mokdong Hospital | Seoul | Korea, Republic of | 07985 | |
75 | The Catholic University of Korea-Seoul St. Marys Hospital | Seoul | Korea, Republic of | 6591 | |
76 | Ulsan University Hospital | Ulsan | Korea, Republic of | 44033 | |
77 | North Shore Hospital | Auckland | New Zealand | 0622 | |
78 | Southern District Hospital | Dunedin | New Zealand | 9054 | |
79 | Szpital Uniwersytecki nr 2 im. | Bydgoszcz | Poland | 85-168 | |
80 | Pratia MCM Krakow | Kraków | Poland | 30-510 | |
81 | Primary Specialty Oncology | Warszawa | Poland | 02-034 | |
82 | Instytut Hematologii i Transfuzjologii | Warszawa | Poland | 02-776 | |
83 | Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku | Wroclaw | Poland | 53-439 | |
84 | ojewodzkie Wielospecjalistyczne Centrum | Łódź | Poland | 93-510 | |
85 | Hospital Universitario de Canarias | La Laguna | Tenerife | Spain | 38320 |
86 | Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
87 | Hospital Universitari Mutua Terrasa | Barcelona | Spain | 08221 | |
88 | ICO-Hospital Duran i Reynals | Barcelona | Spain | 08908 | |
89 | MD Anderson Cancer Center | Madrid | Spain | 28033 | |
90 | Hospital Universitario Ramon y Cajal | Madrid | Spain | 28034 | |
91 | Fundacion Jimenez Diaz | Madrid | Spain | 28040 | |
92 | Hospital Universitario Quiron Salud Madrid | Madrid | Spain | 28223 | |
93 | Complejo Hospitalario de Navarra | Pamplona | Spain | 31008 | |
94 | Hospital Clinico de Salamanca | Salamanca | Spain | 37007 | |
95 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41009 | |
96 | Hospital Virgen del Rocio | Sevilla | Spain | 41013 | |
97 | Miguel Servet Hospital | Zaragoza | Spain | 50009 | |
98 | Ente Ospedaliero Cantonale (EOC) | Bellinzona | Switzerland | 6500 | |
99 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
100 | National Cheng Kung University Hospital | Tainan City | Taiwan | 70403 | |
101 | Chi-Mei Medical Center, Liouying | Tainan | Taiwan | 736 | |
102 | National Taiwan University Hospital NTUH | Taipei City | Taiwan | 10002 | |
103 | North Wales Cancer Treatment Centre, Glan Clwyd Hospital | Rhyl | Denbighire | United Kingdom | LL185UJ |
104 | Royal Marsden Hospital | London | Sutton | United Kingdom | SM25PT |
105 | Nottingham University Hospital | Nottingham | UK | United Kingdom | NG51PB |
106 | Belfast Health and Social Care Trust - Belfast City Hospital | Belfast | United Kingdom | 28040 | |
107 | Royal Cornwall Hospital | Cornwell | United Kingdom | TR1 3LJ | |
108 | e Clatterbridge Cancer Centre | Liverpool | United Kingdom | L78XP | |
109 | Royal Liverpool University Hospital | Liverpool | United Kingdom | L78XP | |
110 | Lewisham and Greenwich University Hospital Lewisham | London | United Kingdom | SE136LH | |
111 | St George's Hospital | London | United Kingdom | SW170QT | |
112 | Centre for Haematology, Imperial College London | London | United Kingdom | W12ONN | |
113 | The Christie NHS Foundation Trust | Manchester | United Kingdom | M20 | |
114 | Norfolk and Norwich University Hospital NHS Foundation Trust | Norwich | United Kingdom | NR4 7UY | |
115 | Oxford University Hospitals | Oxford | United Kingdom | 0X46LB | |
116 | Royal Hallamshire Hospital | Sheffield | United Kingdom | S102JF |
Sponsors and Collaborators
- MEI Pharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ME-401-003
- 2018-002896-17