Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

March 22, 2021

Primary Completion Date

April 17, 2024

Study Completion Date

April 17, 2024

Conditions
Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaEsophageal Adenocarcinoma
Interventions
DRUG

tucatinib

300 mg given twice daily orally

DRUG

trastuzumab

6 mg/kg loading dose will be administered intravenously (IV; into the vein) on Cycle 1 Day 1, followed by 4 mg/kg IV on Cycle 1 Day 15 and then Days 1 and 15 of each cycle thereafter

DRUG

ramucirumab

8 mg/kg will be administered IV on Days 1 and 15 of each cycle

DRUG

paclitaxel

60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle

OTHER

tucatinib placebo

Given twice daily orally

OTHER

trastuzumab placebo

IV on Days 1 and 15 of each cycle

Trial Locations (48)

807

Kaohsiung Medical University Hospital, Kaohsiung City

2250

Central Coast Local Health District (Gosford and Wyong Hospitals), Gosford

10002

National Taiwan University Hospital, Taipei

11217

Taipei Veterans General Hospital, Taipei

13605

Seoul National University Bundang Hospital, Seongnam-si

14203

Roswell Park Cancer Institute, Buffalo

15212

Allegheny General Hospital, Pittsburgh

16499

Ajou University Hospital, Suwon

19104

University of Pennsylvania / Perelman Center for Advanced Medicine, Philadelphia

20007

Lombardi Cancer Center / Georgetown University Medical Center, Washington D.C.

27710

Duke University Medical Center, Durham

35249

University of Alabama at Birmingham, Birmingham

37203

Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville

37920

University of Tennessee, Knoxville

40217

Norton Cancer Institute, Louisville

41404

Kyungpook National University Chilgok Hospital, Daegu

44195

Cleveland Clinic - Taussig Cancer Institute, Cleveland

49201

Dong-A University Hospital, Busan

52242

Holden Comprehensive Cancer Center / University of Iowa, Iowa City

55102

Minnesota Oncology Hematology P.A., Saint Paul

60637

University of Chicago Medical Center, Chicago

75246

Texas Oncology - Baylor Sammons Cancer Center, Dallas

75702

Texas Oncology - Tyler, Tyler

78217

Texas Oncology - San Antonio Medical Center, San Antonio

80012

Rocky Mountain Cancer Centers - Aurora, Aurora

80026

SCL Health Good Samaritan Medical Center Cancer Centers of Colorado, Lafayette

80033

Lutheran Medical Center - Cancer Centers of Colorado, Wheat Ridge

80218

Cancer Centers of Colorado - Denver, Denver

81501

SCL Health - St. Mary's Hospital & Medical Center, Grand Junction

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

85054

Mayo Clinic Arizona, Phoenix

85724

Arizona Cancer Center / University of Arizona, Tucson

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90404

UCLA Medical Center / David Geffen School of Medicine, Santa Monica

91010

City of Hope National Medical Center, Duarte

97401

Oncology Associates of Oregon, Eugene

98684

Northwest Cancer Specialists, P.C., Vancouver

02215

Dana Farber Cancer Institute, Boston

63V6 63

Austin Health, Heidelberg

N6A 5W9

London Regional Cancer Program, London Health Sciences Centre, London

H2X 3E4

Centre Hospitalier de l'Universite de Montreal, Montreal

H4A 3J1

McGill University Department of Oncology / McGill University Health Centre, Montreal

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center - Oncology, Seoul

06351

Samsung Medical Center, Seoul

W3 0ER

Sarah Cannon Research Institute UK, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

All Listed Sponsors
lead

Seagen Inc.

INDUSTRY

NCT04499924 - Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer | Biotech Hunter | Biotech Hunter