Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

NCT04745832 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: ME-401-0042020-004199-16
• Study Type: interventional
• Target: 82
• Locations: 19 countries
• Sites: 141

Brief Summary

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

Conditions

Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  PFS is defined as the time from randomization date until the date of disease progression, or death from any cause

  1 year 7 months

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  1 year 7 months

• Complete Response Rate (CRR)

  1 year 7 months

• Overall Survival

  1 year 7 months

• Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)

  1 year 7 months

• Number of SAEs (Zandelisib When Combined With Rituximab)

  1 year 7 months

Study Arms (2)

Rituximab plus Zandelisib

EXPERIMENTAL

Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles

Drug: Zandelisib; Drug: Rituximab

Rituximab plus chemotherapy

EXPERIMENTAL

Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles

Drug: Rituximab; Drug: Bendamustine; Drug: CHOP

Interventions

Zandelisib DRUG

Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3

Also known as: ME-401

Rituximab plus Zandelisib

Rituximab DRUG

Rituximab IV 375 mg/m2 for 6 cycles

Also known as: Rituxan, MabThera

Rituximab plus Zandelisib; Rituximab plus chemotherapy

Bendamustine DRUG

Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles

Also known as: Bendeka, Treanda, Belrapzo

Rituximab plus chemotherapy

CHOP DRUG

Cyclophosphamide, Vindcristine IV, and Prednisone daily orally

Also known as: cyclophosphamide 750 mg/m2, hydroxydoxorubicin IV 50 mg/m2, vincristine IV 1.4 mg/m2 and prednisone 100 mg daily

Rituximab plus chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years for subjects in Japan and Taiwan
• Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
• FL Gr 1, Gr 2, or Gr 3a
• MZL (splenic, nodal, or extra-nodal)
• Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy
• Subjects must have at least one bi-dimensionally measurable lesion \>1.5 cm
• Adequate hematologic parameters at screening unless abnormal values are due to disease
• Adequate renal and hepatic function
• Adequate cardiac function based on ECG and LVEF assessments

You may not qualify if:

• Histologically confirmed diagnosis of FL Gr 3b or transformed disease
• Prior therapy with PI3K inhibitors
• Ongoing or history of drug-induced pneumonitis
• Known lymphomatous involvement of the central nervous system
• Tested positive for or active viral infection with hepatitis B or C virus
• Tested positive or active infection with human immunodeficiency virus
• Tested positive, or active infection with human T-cell leukemia virus type 1
• Any uncontrolled clinically significant illness
• History of clinically significant cardiovascular abnormalities such as congestive heart failure
• History of clinically significant gastrointestinal (GI) conditions
• Females who are pregnant

Sponsors & Collaborators

• MEI Pharma, Inc.: lead
• Kyowa Kirin, Inc.: collaborator

Study Sites (141)

The Oncology Institute of Hope and Innovation

Tucson, Arizona, 85745, United States

Location

Orange Coast Memorial Medical Center

Fountain Valley, California, 92708, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

The Oncology Institute of Hope and Innovation

Riverside, California, 92506, United States

Location

BRCR Medical Center Inc

Hollywood, Florida, 33021, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Revive Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Revive Research Institute

Sterling Heights, Michigan, 48314, United States

Location

Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center

Springfield, Missouri, 65804, United States

Location

Inspira Medical Center Mullica Hill

Mullica Hill, New Jersey, 08062, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Alpha Research Institute, LLC

Baytown, Texas, 77521, United States

Location

Valley Cancer Associates

Harlingen, Texas, 78550, United States

Location

Community Cancer Trials of Utah

Ogden, Utah, 84405, United States

Location

Canberra Hospital

Garran, 2605, Australia

Location

The Perth Blood Institute (PBI)

West Perth, 6005, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

AZ Sint-Jan Burgge-Oostende AV

Bruges, 8000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 655, 2650, Belgium

Location

Center Hospitalier de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

UZ Leuven Campus Gasthuisberg

Leuven, Belgium

Location

Eastern Regional Health Authority

St. John's, Newfoundland and Labrador, A1B3V6, Canada

Location

Centre intégré universitaire de santé et de services sociaux de l'Estrie

Sherbrooke, Quebec, JIH5N4, Canada

Location

McGill University Health Centre

Québec, H4A 3J1, Canada

Location

CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier De Dunkerque - Service d'hématologie

Le Mans, 72000, France

Location

Centre Hospitalier du Mans

Le Mans, 72000, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

CHU de Bordeaux - Maladies Du Sang, Centre François Magendie

Pessac, 33600, France

Location

Centre Henri Becquerel, Service d'Hematologie

Rouen, 76038, France

Location

CHU de Tours, Hôpital Bretonneau Centre

Tours, 37044, France

Location

Institut De Cancerologie Gustave Roussy

Villejuif, 94805, France

Location

LTD Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, 0112, Georgia

Location

M. Zodelava Hematology Center

Tbilisi, 0112, Georgia

Location

J.S.C. K. Eristavi National Center of Experimental and Clinic

Tbilisi, 0159, Georgia

Location

LTD "Medinvest" Institute of Hematology and Transfusiology

Tbilisi, 0186, Georgia

Location

General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation

Athens, 11527, Greece

Location

University General Hospital of Ioannina, Department of Haematology

Ioannina, 455 00, Greece

Location

University General Hospital of Patras "Panagia H. Voitheia"

Pátrai, 26504, Greece

Location

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, 57010, Greece

Location

Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály

Budapest, H-1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

Debrecen, H-4032, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz,

Nyíregyháza, H-4400, Hungary

Location

SOC Oncologia Medica e dei Tumori Immunocorrelati

Aviano, 33081, Italy

Location

UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle

Cuneo, 12100, Italy

Location

U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

U.O. Clinica Ematologica

Genova, 16132, Italy

Location

SC Oncologia Medica

Meldola, 47014, Italy

Location

UOC Ematologia, Presidio Ospedaliero Papardo

Messina, 98158, Italy

Location

UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre

Mestre, 30174, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

Dipartimento di Oncoematologia, Unità Linfomi, Ospedale

Milan, 20132, Italy

Location

Divisione Oncoematologia, Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Via Sofia

Palermo, 90146, Italy

Location

UO Ematologia, Ospedale Civile S.Maria delle Croci

Ravenna, 48121, Italy

Location

UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna

Rimini, 47923, Italy

Location

Istituti Fisioterapici Ospitalieri

Roma, 00144, Italy

Location

S.C. Oncoematologia Azienda Ospedaliera Santa Maria

Terni, 05110, Italy

Location

National Hospital Organization Nagoya Medical Center

Naka-ku, Aichi-ken, 460-0001, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

National Hospital Organization Kyushu Cancer Center

Minami, Fukuoka, 811-1395, Japan

Location

Gunma University Hospital

Maebashi, Gunma, 371-8511, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Kagoshima University Hospital

Sakuragaoka, Kagoshima-Shi, Kagoshima, 890-8520, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kamigyō-ku, Kyoto, 602-8566, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Anjo Kosei Hospital

Aichi, 446-8602, Japan

Location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Aichi, 466-8650, Japan

Location

Aomori Prefectural Central Hospital

Aomori, 030-8553, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Chugoku Central Hospital

Hiroshima, 720-0001, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

National University Corporation Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Aichi Cancer Center Hospital

Nagoya, 464-8681, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, 113-8677, Japan

Location

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Tokyo, 135-8550, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Albert Schweizer Ziekenhuis, Hematology Department

Dordrecht, 3318, Netherlands

Location

Spaarne Gasthuis, Oncology Department

Hoofddorp, 2134, Netherlands

Location

Canterbury District Health Board, Haematology Department

Christchurch, 8011, New Zealand

Location

Dunedin Hospital, Southern Blood and Cancer Service

Dunedin, 9016, New Zealand

Location

Klinika Hematologii, Szpital Uniwersytecki

Bydgoszcz, 85-168, Poland

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

ARS Medical - Szpital, Oddzial hematologiczny

Piła, 64-920, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60-185, Poland

Location

University Clinical Center of Serbia, Clinic for Hematology

Belgrade, 11000, Serbia

Location

Zvezdara University Medical Center, Clinical department for Hematology and Oncology

Belgrade, 11000, Serbia

Location

Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology

Belgrade, 11080, Serbia

Location

Oncology Institute of Vojvodina, Clinic for Internal Oncology

Kamenica, 21204, Serbia

Location

University Clinical Center Kragujevac, Clinic for Hematology

Kragujevac, 34000, Serbia

Location

Clinical Center of Vojvodina, Clinic for Hematology

Novi Sad, 21000, Serbia

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Dong-A university Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Chonnam National University Hwasun Hospital

Jeollyang, 58128, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea

Seoul, 06591, South Korea

Location

Ewka Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Universitario Quironsalud

Alcorcón, Madrid, 28223, Spain

Location

Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

Location

Hospital Universitario Mútua Terrassa

Barcelona, 08221, Spain

Location

Institut Catalá d'Oncologia, Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Complejo Hospitalario de Navarra

Navarro, 31008, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

China Medical University Hospital

Taichung, 404332, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Chi Mei Hospital

Tainan, 73657, Taiwan

Location

Gazi University Health Research and Application Hospital, Hematology Department

Ankara, 29 06560, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty, Hematology Department

Istanbul, 34093, Turkey (Türkiye)

Location

Erciyes University Medical Faculty, Department of Hematology

Kayseri, 38039, Turkey (Türkiye)

Location

Ondokuz Mayis University Medical Faculty, Hematology Department

Samsun, 55200, Turkey (Türkiye)

Location

Namik Kemal University Hospital

Tekirdağ, 59100, Turkey (Türkiye)

Location

Karadeniz Technical University Medical Faculty Department of Hematology

Trabzon, 61080, Turkey (Türkiye)

Location

North Wales Cancer Treatment Centre

Bodelwyddan, Denbighshire, LL18 5UJ, United Kingdom

Location

Royal Cornwall Hospital

Cornwell, TR1 3LJ, United Kingdom

Location

Department of Haematology St. George's University of London

London, SW17 0RE, United Kingdom

Location

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Imperial College Healthcare NHS Trust Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Genesis Care Oxford

Oxford, OX4 6LB, United Kingdom

Location

University Hospitals Plymouth NHS Trust, Derriford Hopital

Plymouth, PL6 8DH, United Kingdom

Location

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

Surrey Quays, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone

Interventions

ME-401; Rituximab; Bendamustine Hydrochloride; Cyclophosphamide; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Richard Ghalie, MD CMO
• Organization: MEI Pharma

rghalie@meipharma.om

858.898-0956

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1: Rituximab plus Zandelisib Arm 2: Rituximab plus chemotherapy (CHOP or Bendamustine)

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: August 13, 2021
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: November 4, 2024
• Results First Posted: December 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); SE (6); ES (9); KR (13); TU (6); JP (25); BE (5); NL (2); US (14); NZ (2); GE (4); PL (4); AU (3); TW (4); IT (16); CA (3); FR (9); GR (4); GB (9)