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

• ClinicalTrials.gov Identifier: NCT03768505
• Recruitment Status: Recruiting
• First Posted: December 7, 2018
• Last Update Posted: November 9, 2020
• Sponsor: MEI Pharma, Inc.
• Information provided by (Responsible Party): MEI Pharma, Inc.

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
Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma	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 (Clinical Trial)
• Estimated 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 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: December 15, 2018
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: December 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 [ 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 Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: MEI Pharma MEI Pharma; 858-369-7100; Patients@meipharma.com

Locations

United States, Arizona

Oncology Institute of Hope and Innovation; Recruiting

Tucson, Arizona, United States, 85710

United States, California

Pacific Cancer Medical Center, Inc.; Recruiting

Anaheim, California, United States, 92801

Tower Hematology Oncology; Recruiting

Beverly Hills, California, United States, 90211

The Oncology Institute of Hope and Innovation; Recruiting

Downey, California, United States, 90241

Sharp Memorial Hospital; Recruiting

San Diego, California, United States, 92123

United States, Florida

H. Lee Moffit Cancer Center; Recruiting

Tampa, Florida, United States, 33612

Cleveland Clinic-Florida; Recruiting

Weston, Florida, United States, 333331

United States, Illinois

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Advocate Health & Hospitals Corporation; Recruiting

Niles, Illinois, United States, 61761

United States, Indiana

Investigative Clinical Research of Indiana LLC; Recruiting

Indianapolis, Indiana, United States, 46260

United States, Massachusetts

Dana-Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan Medical School; Recruiting

Ann Arbor, Michigan, United States, 48109

United States, Montana

St. Vincent Frontier Cancer Center; Recruiting

Billings, Montana, United States, 59102

United States, Nevada

The Oncology Institute of Hope and Innovation; Recruiting

Henderson, Nevada, United States, 89052

United States, New Jersey

Memorial Sloan Kettering; Recruiting

Basking Ridge, New Jersey, United States, 07920

Memorial Sloan Kettering; Recruiting

Middletown, New Jersey, United States, 07748

Memorial Sloan Kettering; Recruiting

Montvale, New Jersey, United States, 07645

United States, New Mexico

San Juan Oncology; Recruiting

Farmington, New Mexico, United States, 87401

United States, New York

Memorial Sloan Kettering; Recruiting

Commack, New York, United States, 11725

Memorial Sloan Kettering; Recruiting

Harrison, New York, United States, 10604

Clinical Research Alliance; Recruiting

Lake Success, New York, United States, 11042

Memorial Sloan Kettering; Recruiting

New York, New York, United States, 10065

Stony Brook University; Withdrawn

Stony Brook, New York, United States, 11794

Memorial Sloan Kettering; Recruiting

Uniondale, New York, United States, 11553

United States, North Carolina

Duke Cancer Center; Recruiting

Durham, North Carolina, United States, 27710

United States, Ohio

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44195

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

United States, Tennessee

Vanderbilt University; Recruiting

Nashville, Tennessee, United States, 37203

United States, Texas

Renovatio Clinical; Recruiting

Houston, Texas, United States, 77056

United States, Washington

Swedish Cancer Institute; Recruiting

Edmonds, Washington, United States, 98026

Swedish Cancer Institute; Recruiting

Seattle, Washington, United States, 98104

Medical Oncology Associates PS; Recruiting

Spokane, Washington, United States, 99208

Northwest Medical Specialties; Withdrawn

Tacoma, Washington, United States, 98405

United States, Wisconsin

University of Wisconsin Carbone Cancer Center; Recruiting

Madison, Wisconsin, United States, 53705

Marshfield Medical Center; Recruiting

Marshfield, Wisconsin, United States, 54449

Australia, Victoria

Peninsula and South Eastern Haematology and Oncology Group; Recruiting

Frankston, Victoria, Australia, 3199

Australia, Western Australia

The Perth Blood Institute; Recruiting

West Perth, Western Australia, Australia, 6005

Australia

Liverpool Hospital; Recruiting

Sydney, Australia, NSW2170

Austria

Kepler Universitatsklinikum GmBH; Recruiting

Linz, Austria, 4021

Medical University of Vienna; Recruiting

Vienna, Austria, 1160

Belgium

AZ Sint-Jan Brugge-Oostende; Recruiting

Brugge, Belgium, 8000

Institut Jules Bordet; Recruiting

Brussels, Belgium, 1000

Cliniques Universitaires Saint-Luc; Recruiting

Brussels, Belgium, 1200

Antwerp University Hospital; Recruiting

Edegem, Belgium, 2650

France

C H de la Cote Basque, Service d'Hematologie; Recruiting

Bayonne, France, 64100

CHD Vendee, Onco-hematologie; Recruiting

La Roche-Sur-Yon Cedex 9, France, 85925

Centre Hospitalier du Mans; Recruiting

Le Mans, France, F720000

Centre Hospitalier de Mulhouse; Recruiting

Mulhouse, France, 68100

Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie; Recruiting

Poitiers, France, 86021

Institut Gustave Roussy; Recruiting

Villejuif, France, 94805

Germany

Klinikum Mutterhaus Feldstr; Recruiting

Trier, Rheinland-Pfalz, Germany

Hamatologisch-Onkolgische Praxis; Recruiting

Nordheim, Stolberg, Germany, 52222

Universitatsklinikum Halle; Recruiting

Halle, Germany, 06120

Munich Municipal Hospital; Recruiting

Munich, Germany, 80804

Italy

Centro di Riferimento Oncologico di Aviano (CRO) IRCCS; Recruiting

Aviano, Italy, 33081

Policlinico Sant'Orsola Malpighi; Recruiting

Bologna, Italy, 40138

IRCCS AOU Policlinico San Martino; Recruiting

Genova, Italy, 16132

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.; Recruiting

Meldola, Italy, 47014

UOC Oncoematologia; Recruiting

Napoli, Italy, 80131

Ospedale Santa Maria delle Croci; Recruiting

Ravenna, Italy, 48121

Infermi Hospital Rimini; Recruiting

Rimini, Italy, 47923

Universita Cattolica del Sacro Cuore; Recruiting

Roma, Italy, 00168

IRCCS Regina Elena National Cancer Institute; Recruiting

Rome, Italy, 00144

Azienda Ospedaliera Santa Maria; Recruiting

Terni, Italy, 05100

Ospedale DellAngelo Di Mestre Umberto I; Recruiting

Venice, Italy, 30174

Korea, Republic of

Dong-A University Hospital; Recruiting

Busan, Korea, Republic of, 49201

Contact Patients@meipharma.com

Pusan National University Hospital; Recruiting

Busan, Korea, Republic of, 49241

Korea University Anam Hospital; Recruiting

Seoul, Korea, Republic of, 02841

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Asan Medical Center; Recruiting

Seoul, Korea, Republic of, 05505

Contact Patients@meipharma.com

Samsung Medical Center; Recruiting

Seoul, Korea, Republic of, 06351

Ewha Womans University Mokdong Hospital; Recruiting

Seoul, Korea, Republic of, 07985

The Catholic University of Korea-Seoul St. Marys Hospital; Recruiting

Seoul, Korea, Republic of, 6591

Ulsan University Hospital; Recruiting

Ulsan, Korea, Republic of, 44033

New Zealand

North Shore Hospital; Recruiting

Auckland, New Zealand, 0622

Contact: Leo Gonzales-Perez 64 9 486 8920 ext 43702 Leo.Gonzalez-Perez@waitematadhb.govt.nz

Contact: Nuria Lopez Rozain Nuria.LopezRosain@waitematadhb.govt.nz

Southern District Hospital; Recruiting

Dunedin, New Zealand, 9054

Contact: Tracey Steiner 64 (0)3 4740999 ext 59941 tracey.steiner@southerndhb.govt.nz

Contact: Karen Eden 64 (0)3 470 9986 Karen.Eden@southerndhb.govt.nz

Poland

Szpital Uniwersytecki nr 2 im.; Recruiting

Bydgoszcz, Poland, 85-168

Pratia MCM Krakow; Recruiting

Kraków, Poland, 30-510

Contact Patients@meipharma.com

Primary Specialty Oncology; Recruiting

Warszawa, Poland, 02-034

Instytut Hematologii i Transfuzjologii; Recruiting

Warszawa, Poland, 02-776

ojewodzkie Wielospecjalistyczne Centrum; Recruiting

Łódź, Poland, 93-510

Spain

Hospital Universitario de Canarias; Recruiting

La Laguna, Tenerife, Spain, 38320

Hospital Universitari Vall d'Hebron; Recruiting

Barcelona, Spain, 08035

Hospital Universitari Mutua Terrasa; Recruiting

Barcelona, Spain, 08221

ICO-Hospital Duran i Reynals; Recruiting

Barcelona, Spain, 08908

MD Anderson Cancer Center; Recruiting

Madrid, Spain, 28033

Hospital Universitario Ramon y Cajal; Recruiting

Madrid, Spain, 28034

Fundacion Jimenez Diaz; Recruiting

Madrid, Spain, 28040

Hospital Universitario Quiron Salud Madrid; Recruiting

Madrid, Spain, 28223

Complejo Hospitalario de Navarra; Recruiting

Pamplona, Spain, 31008

Hospital Clinico de Salamanca; Recruiting

Salamanca, Spain, 37007

Hospital Universitario Virgen Macarena; Recruiting

Sevilla, Spain, 41009

Hospital Virgen del Rocio; Recruiting

Sevilla, Spain, 41013

Miguel Servet Hospital; Recruiting

Zaragoza, Spain, 50009

Switzerland

Ente Ospedaliero Cantonale (EOC); Recruiting

Bellinzona, Switzerland, 6500

Taiwan

China Medical University Hospital; Recruiting

Taichung, Taiwan, 40447

National Cheng Kung University Hospital; Recruiting

Tainan City, Taiwan, 70403

Chi-Mei Medical Center, Liouying; Recruiting

Tainan, Taiwan, 736

National Taiwan University Hospital NTUH; Recruiting

Taipei City, Taiwan, 10002

United Kingdom

North Wales Cancer Treatment Centre, Glan Clwyd Hospital; Recruiting

Rhyl, Denbighire, United Kingdom, LL185UJ

Royal Marsden Hospital; Recruiting

London, Sutton, United Kingdom, SM25PT

Nottingham University Hospital; Recruiting

Nottingham, UK, United Kingdom, NG51PB

Belfast Health and Social Care Trust - Belfast City Hospital; Recruiting

Belfast, United Kingdom, 28040

Royal Cornwall Hospital; Recruiting

Cornwell, United Kingdom, TR1 3LJ

e Clatterbridge Cancer Centre; Recruiting

Liverpool, United Kingdom, L78XP

Royal Liverpool University Hospital; Recruiting

Liverpool, United Kingdom, L78XP

Lewisham and Greenwich University Hospital Lewisham; Recruiting

London, United Kingdom, SE136LH

St George's Hospital; Recruiting

London, United Kingdom, SW170QT

Centre for Haematology, Imperial College London; Recruiting

London, United Kingdom, W12ONN

The Christie NHS Foundation Trust; Recruiting

Manchester, United Kingdom, M20

Norfolk and Norwich University Hospital NHS Foundation Trust; Recruiting

Norwich, United Kingdom, NR4 7UY

Oxford University Hospitals; Recruiting

Oxford, United Kingdom, 0X46LB

Royal Hallamshire Hospital; Recruiting

Sheffield, United Kingdom, S102JF

Sponsors and Collaborators

MEI Pharma, Inc.

More Information

Additional Information:

study website 

• Responsible Party: MEI Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT03768505
• Other Study ID Numbers: ME-401-003; 2018-002896-17 ( EudraCT Number )
• First Posted: December 7, 2018
• Last Update Posted: November 9, 2020
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• 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:

Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell