Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
NCT ID: NCT04499924
Last Updated: 2025-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
17 participants
INTERVENTIONAL
2021-03-22
2024-04-17
Brief Summary
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Study treatment will be given in 28-day cycles.
In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Phase 2 Arm
Tucatinib + trastuzumab + ramucirumab + paclitaxel
tucatinib
300 mg given twice daily orally
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
ramucirumab
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
paclitaxel
60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle
Arm 3A
Tucatinib + trastuzumab + ramucirumab + paclitaxel
tucatinib
300 mg given twice daily orally
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
ramucirumab
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
paclitaxel
60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle
Arm 3B
Ramucirumab + paclitaxel + tucatinib placebo + trastuzumab placebo
ramucirumab
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
paclitaxel
60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle
tucatinib placebo
Given twice daily orally
trastuzumab placebo
IV on Days 1 and 15 of each cycle
Arm 3C
Tucatinib + ramucirumab + paclitaxel + trastuzumab placebo
tucatinib
300 mg given twice daily orally
ramucirumab
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
paclitaxel
60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle
trastuzumab placebo
IV on Days 1 and 15 of each cycle
Interventions
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tucatinib
300 mg given twice daily orally
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
ramucirumab
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
paclitaxel
60 or 80 mg/m\^2 IV on Days 1, 8, and 15 of each cycle
tucatinib placebo
Given twice daily orally
trastuzumab placebo
IV on Days 1 and 15 of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2+ disease documented since progression of the most recent line of systemic therapy, as follows:
* Phase 2 paclitaxel dose optimization stage:
* HER2 amplification in a blood-based NGS assay performed at a central laboratory, or
* HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
* Phase 2 dose expansion stage:
* Cohort 2A: HER2 amplification in a blood-based NGS assay performed at a central laboratory
* Cohort 2B: No HER2 amplification by blood-based NGS assay, but HER2 overexpression/amplification by IHC and ISH (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
* Phase 3: HER2 amplification in a blood-based NGS assay performed at a central laboratory
* History of prior treatment with a HER2-directed antibody
* Progressive disease during or after first-line therapy for locally-advanced unresectable or metastatic GEC
* Phase 2: Measurable disease according to RECIST version 1.1
* Phase 3: Measurable or non-measurable disease according to RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Life expectancy of at least 3 months, in the opinion of the investigator
Exclusion Criteria
* Having received more than 1 line of prior systemic therapy for locally-advanced unresectable or metastatic disease
* Having received taxanes ≤12 months prior to enrollment, prior treatment with ramucirumab, or prior treatment with tucatinib, lapatinib, neratinib, afatinib, or any other investigational anti-HER2 and/or anti-EGFR tyrosine kinase inhibitor, or with T-DM1, T-Dxd, or any other HER2-directed antibody-drug conjugate
* Phase 2 paclitaxel dose optimization stage only: history of prior partial or total gastrectomy
* Unable to swallow pills
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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JoAl Mayor, PharmD, BCOP
Role: STUDY_DIRECTOR
Seagen Inc.
Michelle Ubowski, PharmD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Arizona Cancer Center / University of Arizona
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
UCLA Medical Center / David Geffen School of Medicine
Santa Monica, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Cancer Centers of Colorado - Denver
Denver, Colorado, United States
SCL Health - St. Mary's Hospital & Medical Center
Grand Junction, Colorado, United States
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
Lafayette, Colorado, United States
Lutheran Medical Center - Cancer Centers of Colorado
Wheat Ridge, Colorado, United States
Lombardi Cancer Center / Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Holden Comprehensive Cancer Center / University of Iowa
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Minnesota Oncology Hematology P.A.
Saint Paul, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Tennessee
Knoxville, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Central Coast Local Health District (Gosford and Wyong Hospitals)
Gosford, , Australia
Austin Health
Heidelberg, , Australia
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
McGill University Department of Oncology / McGill University Health Centre
Montreal, Quebec, Canada
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center - Oncology
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Sarah Cannon Research Institute UK
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C4251004
Identifier Type: OTHER
Identifier Source: secondary_id
SGNTUC-022
Identifier Type: -
Identifier Source: org_study_id
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