NCT04879368 - RegoNivo vs Standard of Care Chemotherapy in AGOC | Biotech Hunter

Enrollment

450

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

July 9, 2025

Study Completion Date

June 1, 2026

Conditions

Gastro-Oesophageal Cancer

Interventions

DRUG

Regorafenib

Oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases

BIOLOGICAL

Nivolumab

human IgG4 monoclonal antibody inhibitor of PD-1

DRUG

Docetaxel

"Docetaxel is taxane-derivative chemotherapy drug, used in the treatment of early, locally advanced and metastatic breast cancer. It is an anti-microtubule agent. Other uses are in the treatment of non-small cell lung cancer, advanced stomach cancer, head and neck cancers, soft tissue sarcoma, ovarian cancer, metastatic prostate cancer, etc.~microtubules, and simultaneously promotes assembly and inhibits disassembly of them"

DRUG

Paclitaxel

Paclitaxel is one of several cytoskeletal drugs that target tubulin. Paclitaxel-treated cells have defects in mitotic spindle assembly, chromosome segregation, and cell division. Unlike other tubulin-targeting drugs, such as colchicine, that inhibit microtubule assembly, paclitaxel stabilizes the microtubule polymer and protects it from disassembly. Chromosomes are thus unable to achieve a metaphase spindle configuration. This blocks the progression of mitosis and prolonged activation of the mitotic checkpoint triggers apoptosis or reversion to the G0-phase of the cell cycle without cell division

DRUG

Irinotecan

Camptothecin, one of the four major structural classifications of plant-derived anti-cancerous compounds, is a cytotoxic alkaloid which consists of a pentacyclic ring structure containing a pyrrole (3, 4 β) quinoline moiety, an S-configured lactone form, and a carboxylate form. Irinotecan is activated by hydrolysis to SN-38, an inhibitor of topoisomerase I. This is then inactivated by glucuronidation by uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1). The inhibition of topoisomerase I by the active metabolite SN-38 eventually leads to inhibition of both DNA replication and transcription.

DRUG

Trifluridine/Tipracil

The drug consists of the cytotoxin trifluridine and the thymidine phosphorylase inhibitor (TPI) tipiracil. Trifluridine is incorporated into DNA during DNA synthesis and inhibits tumor cell growth. Trifluridine (TFT) is incorporated into DNA by phosphorylation by thymidylate kinase (TK) to TF-TMP; TF-TMP then covalently binds to tyrosine 146 of the active site of thymidylate synthase (TS) inhibiting the enzyme's activity. TS is vital to the synthesis of DNA because it is an enzyme involved in the synthesis of the deoxynucleotide, thymidine triphosphate (dTTP). Inhibition of TS depletes the cell of dTTP and causes accumulation of deoxyuridine monophosphate (dUMP), which increases the likelihood that uracil gets misincorporated into the DNA.

Trial Locations (94)

700

Royal Hobart Hospital, Hobart

2010

St Vincent's Public Hospital, Darlinghurst

2031

Prince of Wales Hospital, Randwick

2035

Newcastle Private Hospital, New Lambton Heights

2065

Royal North Shore Private Hospital, Sydney

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2217

St George Hospital, Kogarah

2250

Gosford Hospital, Gosford

2444

Port Macquarie Base Hospital, Port Macquarie

2450

Coffs Harbour Health Campus, Coffs Harbour

2485

The Tweed Hospital, Tweed Heads

2640

Border Medical Oncology Research Unit, East Albury

3084

Austin Health, Melbourne

3168

Monash Health, Clayton

3355

Ballarat Oncology and Haematology Services, Wendouree

4029

Royal Brisbane and Womens Hospital, Herston

4560

Sunshine Coast University Hospital, Sunshine Coast

4814

The Townsville Hospital, Douglas

5011

The Queen Elizabeth Hospital, Adelaide

5042

Flinders Medical Centre, Bedford Park

6008

St John of God Hospital Subiaco, Subiaco

6009

Sir Charles Gairdner Hospital, Nedlands

41017

St Elizabeth Healthcare, Edgewood

51101

Siouxland Regional Cancer Center, Sioux City

57701

Monument Health Rapid City Hospital, Rapid City

85054

Mayo Clinic Arizona, Scottsdale

90001

USC Norris, Los Angeles

98109

Fred Hutchinson Cancer Research Centre - South Lake Union Clinic, Seattle

0810

Royal Darwin Hospital, Tiwi

Unknown

Landeskrankenanstalten-Betriebsgesellschaft-KABEG, Klagenfurt

Ordensklinikum Linz GmbH Barmherzige schwestern, Linz

Medizinische Universitaet Wien, Vienna

Landesklinikum Wiener Neustadt, Wiener Neustadt

Evang. Klinikum Bethel Bielefeld, Gütersloh

Helios Bad Saarow, Bad Saarow

Klinikum Bayreuth, Bayreuth

Charité Universitätsmedizin Berlin, Berlin

Universitätsklinikum Bonn, Bonn

Kliniken der Stadt Köln, Cologne

KEM/Evang. Kliniken Essen Mitte gGmbH, Essen

Institut für Klinisch Onkol Forschung am Krankenhaus Nordwest, Frankfurt

Universitätsklinikum Greifswald, Greifswald

Norddeutsches Studienzentrum für Innovative Onkologie (NIO), Hamburg

Universitätsklinikum Heidelberg, Heidelberg

Universitätsklinikum Jena, Jena

Universitätsklinikum Leipzig, Leipzig

Klinikum Leverkusen gGmbH, Leverkusen

Klinikum Ludwigburg, Ludwigsburg

Klinikum Magdeburg gGmbH, Magdeburg

Universitätsklinikum Mainz, Mainz

Philipps-Universitat Marburg, Marburg

Klinikum rechts der Isar der TU München, München

Studienzentrum Onkologie Ravensburg, Ravensburg

Caritas Klinikum Saarbrücken St. Theresia, Saarbrücken

Universitätsklinikum Ulm, Ulm

Istituto Nazionale Tumori di Napoli-IRCCS Fondazione G. Pascale, Napoli

"Universitae degli studi della Campania Luigi Vanvitelli", Napoli

Azienda USL-IRCCS Di Reggio Emilia, Reggio Emilia

San Camillo Forlanini Hospitals, Roma

Universita Cattolica del Sacro Cuore, University Hospital Gemelli, Roma

IRCCS Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo

National Cancer Centre Hospital East, Chiba

Hokkaido University Hospital, Sapporo

Kyushu Cancer Center, Fukuoka

Shikoku Cancer Center, Matsuyama

Saitama Cancer Center, Saitama

Shizuoka Cancer Center, Shizuoka

Hallym University Sacred Heart Hospital, Anyang

Dong-A University Hospital, Busan

Haeundae Paik Hospital, Busan

Chungbuk National University Hospital, Cheongju-si

Jeonbuk National University Hospital, Jeonju

Gyeongsang National University Hospital, Jinju

Asan Medical Centre, Seoul

Chung-Ang University Hospital, Seoul

Kangbuk Samsung Hospital, Seoul

Korea University Anam Hospital, Seoul

Korea University Guro Hospital, Seoul

Seoul National University Bundang Hospital, Seoul

Seoul National University Hospital, Seoul

SMG-SNU Boramae Medical Center, Seoul

The Catholic University of Korea - Seoul St. Mary's Hospital, Seoul

The Catholic University of Korea - Yeouido St. Mary's Hospital, Seoul

Yonsei University Health System - Gangnam Severance Hospital, Seoul

Yonsei University Health System - Severance Hospital, Seoul

Vall d'Hebron University Hospital, Barcelona

Hospital Universitario de Navarra, Pamplona

Hospital Clinico Universitario De Valencia, Valencia

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

China Medical University Hospital (CMUH), Taichung

National Cheng Kung University Hospital, Taipei

National Taiwan University Hospital (NTUH), Taipei

Taipei Veterans General Hospital (TPVGH), Taipei