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

Sponsor
MEI Pharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03768505
Collaborator
(none)
180
116
1
69.2
1.6
0

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
  • Drug: Zandelisib (ME-401)
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

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent scheduleTreatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 25, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

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

  1. 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

  1. 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

  2. Complete response (CR) rate [2 years]

    Complete response rate will be measured by the number of subjects that achieve CR

  3. 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

  4. Overall Survival [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) [2 years]

    The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.

  6. PK of ME-401 [6 months]

    The PK of ME-401 will be determined by the peak plasma concentration (Cmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.
Responsible Party:
MEI Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT03768505
Other Study ID Numbers:
  • ME-401-003
  • 2018-002896-17
First Posted:
Dec 7, 2018
Last Update Posted:
Aug 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022