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Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer (MOUNTAINEER-02)

Primary Purpose

Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tucatinib
trastuzumab
ramucirumab
paclitaxel
tucatinib placebo
trastuzumab placebo
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring HER2+, HER2-positive, GEA, GEC, GEJ, Seattle Genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)

  • 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:

  • Subjects with squamous cell or undifferentiated GEC
  • 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

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Arizona
  • Arizona Cancer Center / University of Arizona
  • City of Hope National Medical Center
  • UCLA Medical Center / David Geffen School of Medicine
  • Rocky Mountain Cancer Centers - Aurora
  • Cancer Centers of Colorado - Denver
  • SCL Health - St. Mary's Hospital & Medical Center
  • SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
  • Lutheran Medical Center - Cancer Centers of Colorado
  • Lombardi Cancer Center / Georgetown University Medical Center
  • University of Chicago Medical Center
  • Holden Comprehensive Cancer Center / University of Iowa
  • Norton Cancer Institute
  • Dana Farber Cancer Institute
  • Minnesota Oncology Hematology P.A.
  • Comprehensive Cancer Centers of Nevada
  • Roswell Park Cancer Institute
  • Duke University Medical Center
  • Cleveland Clinic - Taussig Cancer Institute
  • Oncology Associates of Oregon
  • University of Pennsylvania / Perelman Center for Advanced Medicine
  • Allegheny General Hospital
  • University of Tennessee
  • Tennessee Oncology-Nashville/Sarah Cannon Research Institute
  • Texas Oncology - Baylor Sammons Cancer Center
  • Texas Oncology - San Antonio Medical Center
  • Texas Oncology - Tyler
  • Huntsman Cancer Institute/University of Utah
  • Northwest Cancer Specialists, P.C.
  • Central Coast Local Health District (Gosford and Wyong Hospitals)
  • Austin Health
  • London Regional Cancer Program, London Health Sciences Centre
  • Centre Hospitalier de l'Universite de Montreal
  • McGill University Department of Oncology / McGill University Health Centre
  • Dong-A University Hospital
  • Kyungpook National University Chilgok Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center - Oncology
  • Samsung Medical Center
  • Ajou University Hospital
  • Kaohsiung Medical University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Sarah Cannon Research Institute UK
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Phase 2 Arm

Arm 3A

Arm 3B

Arm 3C

Arm Description

Tucatinib + trastuzumab + ramucirumab + paclitaxel

Tucatinib + trastuzumab + ramucirumab + paclitaxel

Ramucirumab + paclitaxel + tucatinib placebo + trastuzumab placebo

Tucatinib + ramucirumab + paclitaxel + trastuzumab placebo

Outcomes

Primary Outcome Measures

Overall survival (OS) (Phase 3 only)
OS is defined as the time from randomization to death due to any cause
Progression-free survival (PFS) per Response evaluation criteria in solid tumors (RECIST) version 1.1 according to investigator assessment (Phase 3 only)
PFS is defined as the time from randomization to the date of disease progression or death from any cause
Incidence of dose-limiting toxicities (DLTs) (Phase 2 only)
Incidence of adverse events (AEs) (Phase 2 only)
An adverse event is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities (Phase 2 only)
To be summarized using descriptive statistics.
Incidence of dose modifications (Phase 2 only)

Secondary Outcome Measures

Confirmed objective response rate (ORR) per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
ORR is defined as the proportion of subjects with best overall response of CR or PR
ORR per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
ORR is defined as the proportion of subjects with best overall response of CR or PR
Duration of response (DOR) per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
DOR is defined as the time from first documentation of objective response of CR or PR to the first documentation of disease progression or death from any cause
Disease control rate (DCR) per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
DCR is defined as subjects with CR, PR, or stable disease (SD or non-CR/non-progressive disease)
PFS per RECIST v1.1 according to blinded independent central review (BICR) assessment (Phase 3 only)
PFS is defined as the time from randomization to the date of disease progression or death from any cause
Confirmed ORR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
ORR is defined as the proportion of subjects with best overall response of CR or PR
ORR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
ORR is defined as the proportion of subjects with best overall response of CR or PR
DOR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
DOR is defined as the time from first documentation of objective response of CR or PR to the first documentation of disease progression or death from any cause
DCR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
DCR is defined as subjects with CR, PR, or stable disease (SD or non-CR/non-progressive disease)
Incidence of AEs (Phase 3 only)
An adverse event is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities (Phase 3 only)
To be summarized using descriptive statistics.
Incidence of dose modifications (Phase 3 only)
PFS per RECIST version 1.1 according to investigator assessment (Phase 2 only)
PFS is defined as the time from the date of treatment initiation to the date of disease progression or death from any cause
Area under the plasma concentration-time curve (AUC) to the time of the last quantifiable concentration (AUClast) of tucatinib (Phase 2 only)
Pharmacokinetic (PK) parameter
AUC to AUClast of paclitaxel (Phase 2 only)
PK parameter
Maximum observed concentration (Cmax) of tucatinib (Phase 2 only)
PK parameter
Cmax of paclitaxel (Phase 2 only)
PK parameter
Time of Cmax (Tmax) of tucatinib (Phase 2 only)
PK parameter
Tmax of paclitaxel (Phase 2 only)
PK parameter
Trough concentration (Ctrough) of tucatinib (Phase 2 only)
PK parameter
Ctrough of paclitaxel (Phase 2 only)
PK parameter
Metabolic ratio of tucatinib based on AUC (MRAUC) (Phase 2 only)
PK parameter
MRAUC of paclitaxel (Phase 2 only)
PK parameter
Time to deterioration of GEC symptoms as assessed by the European Organisation for Research and Treatment or Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and EORTC QLQ-OG25 questionnaires.
The EORTC questionnaires measure aspects of health-related quality of life (HRQoL). Time to deterioration will be assessed in specific pre-specified single items from either the EORTC QLQ-C30 or EORTC QLQ OG25 and deterioration is defined as a 10-point increase from baseline in the symptom scales and a 10-point decrease from baseline for overall HRQoL.
Change from baseline in health-related quality of life (HRQoL)
Utility index values as assessed by the EQ-5D-5L
The EQ-5D-5L questionnaire is used as a preference based measurement of HRQoL outcomes. Data will be summarized using descriptive statistics.

Full Information

First Posted
July 31, 2020
Last Updated
August 28, 2023
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04499924
Brief Title
Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer
Acronym
MOUNTAINEER-02
Official Title
A Randomized, Double-blind, Placebo-controlled, Active Comparator Phase 2/3 Study of Tucatinib in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Subjects With Previously Treated, Locally-advanced Unresectable or Metastatic HER2+ Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
Keywords
HER2+, HER2-positive, GEA, GEC, GEJ, Seattle Genetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Arm
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + ramucirumab + paclitaxel
Arm Title
Arm 3A
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + ramucirumab + paclitaxel
Arm Title
Arm 3B
Arm Type
Active Comparator
Arm Description
Ramucirumab + paclitaxel + tucatinib placebo + trastuzumab placebo
Arm Title
Arm 3C
Arm Type
Experimental
Arm Description
Tucatinib + ramucirumab + paclitaxel + trastuzumab placebo
Intervention Type
Drug
Intervention Name(s)
tucatinib
Other Intervention Name(s)
TUKYSA, ONT-380, ARRY-380
Intervention Description
300 mg given twice daily orally
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ramucirumab
Other Intervention Name(s)
CYRAMZA
Intervention Description
8 mg/kg will be administered IV on Days 1 and 15 of each cycle
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
60 or 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle
Intervention Type
Other
Intervention Name(s)
tucatinib placebo
Intervention Description
Given twice daily orally
Intervention Type
Other
Intervention Name(s)
trastuzumab placebo
Intervention Description
IV on Days 1 and 15 of each cycle
Primary Outcome Measure Information:
Title
Overall survival (OS) (Phase 3 only)
Description
OS is defined as the time from randomization to death due to any cause
Time Frame
60 months
Title
Progression-free survival (PFS) per Response evaluation criteria in solid tumors (RECIST) version 1.1 according to investigator assessment (Phase 3 only)
Description
PFS is defined as the time from randomization to the date of disease progression or death from any cause
Time Frame
36 months
Title
Incidence of dose-limiting toxicities (DLTs) (Phase 2 only)
Time Frame
During first cycle of treatment; up to one month
Title
Incidence of adverse events (AEs) (Phase 2 only)
Description
An adverse event is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time Frame
18 months
Title
Incidence of laboratory abnormalities (Phase 2 only)
Description
To be summarized using descriptive statistics.
Time Frame
18 months
Title
Incidence of dose modifications (Phase 2 only)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Confirmed objective response rate (ORR) per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
Description
ORR is defined as the proportion of subjects with best overall response of CR or PR
Time Frame
36 months
Title
ORR per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
Description
ORR is defined as the proportion of subjects with best overall response of CR or PR
Time Frame
36 months
Title
Duration of response (DOR) per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
Description
DOR is defined as the time from first documentation of objective response of CR or PR to the first documentation of disease progression or death from any cause
Time Frame
36 months
Title
Disease control rate (DCR) per RECIST version 1.1 according to investigator assessment (Phases 2 and 3)
Description
DCR is defined as subjects with CR, PR, or stable disease (SD or non-CR/non-progressive disease)
Time Frame
36 months
Title
PFS per RECIST v1.1 according to blinded independent central review (BICR) assessment (Phase 3 only)
Description
PFS is defined as the time from randomization to the date of disease progression or death from any cause
Time Frame
36 months
Title
Confirmed ORR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
Description
ORR is defined as the proportion of subjects with best overall response of CR or PR
Time Frame
36 months
Title
ORR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
Description
ORR is defined as the proportion of subjects with best overall response of CR or PR
Time Frame
36 months
Title
DOR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
Description
DOR is defined as the time from first documentation of objective response of CR or PR to the first documentation of disease progression or death from any cause
Time Frame
36 months
Title
DCR per RECIST version 1.1 according to BICR assessment (Phase 3 only)
Description
DCR is defined as subjects with CR, PR, or stable disease (SD or non-CR/non-progressive disease)
Time Frame
36 months
Title
Incidence of AEs (Phase 3 only)
Description
An adverse event is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time Frame
36 months
Title
Incidence of laboratory abnormalities (Phase 3 only)
Description
To be summarized using descriptive statistics.
Time Frame
36 months
Title
Incidence of dose modifications (Phase 3 only)
Time Frame
36 months
Title
PFS per RECIST version 1.1 according to investigator assessment (Phase 2 only)
Description
PFS is defined as the time from the date of treatment initiation to the date of disease progression or death from any cause
Time Frame
18 months
Title
Area under the plasma concentration-time curve (AUC) to the time of the last quantifiable concentration (AUClast) of tucatinib (Phase 2 only)
Description
Pharmacokinetic (PK) parameter
Time Frame
1 month
Title
AUC to AUClast of paclitaxel (Phase 2 only)
Description
PK parameter
Time Frame
1 month
Title
Maximum observed concentration (Cmax) of tucatinib (Phase 2 only)
Description
PK parameter
Time Frame
1 month
Title
Cmax of paclitaxel (Phase 2 only)
Description
PK parameter
Time Frame
1 month
Title
Time of Cmax (Tmax) of tucatinib (Phase 2 only)
Description
PK parameter
Time Frame
1 month
Title
Tmax of paclitaxel (Phase 2 only)
Description
PK parameter
Time Frame
1 month
Title
Trough concentration (Ctrough) of tucatinib (Phase 2 only)
Description
PK parameter
Time Frame
18 months
Title
Ctrough of paclitaxel (Phase 2 only)
Description
PK parameter
Time Frame
18 months
Title
Metabolic ratio of tucatinib based on AUC (MRAUC) (Phase 2 only)
Description
PK parameter
Time Frame
1 month
Title
MRAUC of paclitaxel (Phase 2 only)
Description
PK parameter
Time Frame
1 month
Title
Time to deterioration of GEC symptoms as assessed by the European Organisation for Research and Treatment or Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and EORTC QLQ-OG25 questionnaires.
Description
The EORTC questionnaires measure aspects of health-related quality of life (HRQoL). Time to deterioration will be assessed in specific pre-specified single items from either the EORTC QLQ-C30 or EORTC QLQ OG25 and deterioration is defined as a 10-point increase from baseline in the symptom scales and a 10-point decrease from baseline for overall HRQoL.
Time Frame
36 months
Title
Change from baseline in health-related quality of life (HRQoL)
Time Frame
36 months
Title
Utility index values as assessed by the EQ-5D-5L
Description
The EQ-5D-5L questionnaire is used as a preference based measurement of HRQoL outcomes. Data will be summarized using descriptive statistics.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC) 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: Subjects with squamous cell or undifferentiated GEC 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAl Mayor, PharmD, BCOP
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michelle Ubowski, PharmD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Arizona Cancer Center / University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA Medical Center / David Geffen School of Medicine
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Cancer Centers of Colorado - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
SCL Health - St. Mary's Hospital & Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Lutheran Medical Center - Cancer Centers of Colorado
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Lombardi Cancer Center / Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Holden Comprehensive Cancer Center / University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Minnesota Oncology Hematology P.A.
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic - Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oncology Associates of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
University of Pennsylvania / Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Northwest Cancer Specialists, P.C.
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Central Coast Local Health District (Gosford and Wyong Hospitals)
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
63V6 63
Country
Australia
Facility Name
London Regional Cancer Program, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
McGill University Department of Oncology / McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13605
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center - Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Sarah Cannon Research Institute UK
City
London
ZIP/Postal Code
W3 0ER
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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