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Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

Primary Purpose

Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
tucatinib
trastuzumab
oxaliplatin
leucovorin
fluorouracil
capecitabine
pembrolizumab
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Carcinoma focused on measuring HER2+, HER2-positive, CRC, Gastric cancer, Esophageal cancer, Seattle Genetics

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:

    • Cohorts 1A, 1B, 1C, and 1D

      • CRC
      • Gastric adenocarcinoma
      • GEJ adenocarcinoma
      • Esophageal adenocarcinoma
      • Cholangiocarcinoma
      • Gallbladder carcinoma

    • Cohorts 1E, 1F, 1G, and 2A

      • Gastric adenocarcinoma
      • GEJ adenocarcinoma
      • Esophageal adenocarcinoma

    • Cohort 2B

      • CRC
  • Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G.
  • HER2+ disease, as determined by historic or local laboratory testing
  • Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator
  • Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator
  • Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Exclusion Criteria:

  • History of known hypersensitivity to planned study treatment
  • Known to be positive for Hepatitis B or C
  • For Cohorts 2A and 2B: prior anti-HER2 therapies
  • For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Sites / Locations

  • Mayo Clinic Arizona
  • Stanford Cancer Center / Blood and Marrow Transplant Program
  • University of Colorado Hospital / University of Colorado
  • SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
  • Johns Hopkins Medical CenterRecruiting
  • H. Lee Moffitt Cancer Center and Research Institute
  • University of Chicago Medical Center
  • Mayo Clinic Rochester
  • Washington University in St LouisRecruiting
  • New Mexico Cancer CenterRecruiting
  • Levine Cancer InstituteRecruiting
  • Duke University Medical Center
  • Gabrail Cancer Center Research, LLC
  • Cleveland Clinic, The
  • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of WashingtonRecruiting
  • National Cancer Center Hospital
  • National Cancer Center Hospital East
  • St. Marianna University School of Medicine
  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Aichi Cancer CenterRecruiting
  • Kindai University Hospital
  • Osaka International Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1A

Cohort 1B

Cohort 1C

Cohort 1D

Cohort 1E

Cohort 1F

Cohort 1G

Cohort 2A

Cohort 2B

Arm Description

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles

Tucatinib + trastuzumab + CAPOX given in 21-day cycles

Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days

Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles

Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.

Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.

Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.

Outcomes

Primary Outcome Measures

Incidence of renal dose-limiting toxicities (DLTs) (Cohorts 1A and 1B)
Incidence of adverse events (AEs) (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)
An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)
Incidence of DLTs (Cohorts 1C, 1D, 1E, 1F, and 1G)
Incidence of dose alterations (Cohort 1D)

Secondary Outcome Measures

Incidence of AEs (Cohorts 1A and 1B)
An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities (Cohorts 1A and 1B)
Change in glomerular filtration rate (GFR) from baseline through 2 cycles of combination therapy (Cohorts 1A and 1B)
To be summarized using descriptive statistics
Pharmacokinetic (PK) parameter of tucatinib - AUClast (Cohorts 1A and 1B)
To be summarized using descriptive statistics
PK parameter of tucatinib - Cmax (Cohorts 1A and 1B)
To be summarized using descriptive statistics
PK parameter of tucatinib - Ctrough (Cohorts 1A, 1B, 1C, 1E, 1F, and 1G)
To be summarized using descriptive statistics
PK parameter of tucatinib - Tmax (Cohorts 1A and 1B)
To be summarized using descriptive statistics
PK parameter of oxaliplatin - AUClast (Cohorts 1A and 1B)
To be summarized using descriptive statistics
PK parameter of oxaliplatin - Cmax (Cohorts 1A and 1B)
To be summarized using descriptive statistics
PK parameter of oxaliplatin - Tmax (Cohorts 1A and 1B)
To be summarized using descriptive statistics
Confirmed objective response rate (cORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment (INV) (Cohort 2A)
cORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR)
Duration of response (DOR) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)
DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression or death from any cause, whichever occurs first.
Progression-free survival (PFS) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)
PFS is defined as the time from the date of treatment initiation to the date of disease progression or death from any cause, which occurs first.
Overall survival (OS) (Cohort 1C, 1E, 1F, 1G, and 2A)
OS is defined as the time from treatment initiation to death due to any cause
Objective response rate (ORR) (Cohorts 1C, 1E, 1F, and 1G)
ORR is defined as the proportion of subjects with confirmed CR or PR, according to RECIST v1.1.

Full Information

First Posted
June 10, 2020
Last Updated
October 13, 2023
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04430738
Brief Title
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Official Title
A Phase 1b/2 Dose Escalation and Expansion Study of Tucatinib in Combination With Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (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
No

5. Study Description

Brief Summary
This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will 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. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Esophageal Adenocarcinoma, Cholangiocarcinoma, Gallbladder Carcinoma
Keywords
HER2+, HER2-positive, CRC, Gastric cancer, Esophageal cancer, Seattle Genetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1A
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Arm Title
Cohort 1B
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
Arm Title
Cohort 1C
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + CAPOX given in 21-day cycles
Arm Title
Cohort 1D
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days
Arm Title
Cohort 1E
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles
Arm Title
Cohort 1F
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.
Arm Title
Cohort 1G
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Arm Title
Cohort 2A
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
Arm Title
Cohort 2B
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.
Intervention Type
Drug
Intervention Name(s)
tucatinib
Other Intervention Name(s)
TUKYSA
Intervention Description
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Intervention Description
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
leucovorin
Intervention Description
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
1000 mg/m^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
Intervention Type
Drug
Intervention Name(s)
pembrolizumab
Other Intervention Name(s)
KEYTRUDA
Intervention Description
400 mg given by IV on day 1 of cycle 1, then every 6 weeks.
Primary Outcome Measure Information:
Title
Incidence of renal dose-limiting toxicities (DLTs) (Cohorts 1A and 1B)
Time Frame
Up to one month; 2 cycles after receiving all study treatment (each cycle is 14 days)
Title
Incidence of adverse events (AEs) (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)
Description
An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to approximately 12 months
Title
Incidence of laboratory abnormalities (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)
Time Frame
Up to approximately 12 months
Title
Incidence of DLTs (Cohorts 1C, 1D, 1E, 1F, and 1G)
Time Frame
Up to approximately 12 months
Title
Incidence of dose alterations (Cohort 1D)
Time Frame
Up to approximately 12 months
Secondary Outcome Measure Information:
Title
Incidence of AEs (Cohorts 1A and 1B)
Description
An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to approximately 12 months
Title
Incidence of laboratory abnormalities (Cohorts 1A and 1B)
Time Frame
Up to approximately 12 months
Title
Change in glomerular filtration rate (GFR) from baseline through 2 cycles of combination therapy (Cohorts 1A and 1B)
Description
To be summarized using descriptive statistics
Time Frame
Up to approximately 6 weeks
Title
Pharmacokinetic (PK) parameter of tucatinib - AUClast (Cohorts 1A and 1B)
Description
To be summarized using descriptive statistics
Time Frame
Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
Title
PK parameter of tucatinib - Cmax (Cohorts 1A and 1B)
Description
To be summarized using descriptive statistics
Time Frame
Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
Title
PK parameter of tucatinib - Ctrough (Cohorts 1A, 1B, 1C, 1E, 1F, and 1G)
Description
To be summarized using descriptive statistics
Time Frame
Up to approximately 2.5 months; through predose of Cycle 6, Day 1
Title
PK parameter of tucatinib - Tmax (Cohorts 1A and 1B)
Description
To be summarized using descriptive statistics
Time Frame
Up to approximately 2.5 months; through predose of Cycle 2, Day 1 (each cycle is 14 days)
Title
PK parameter of oxaliplatin - AUClast (Cohorts 1A and 1B)
Description
To be summarized using descriptive statistics
Time Frame
Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
Title
PK parameter of oxaliplatin - Cmax (Cohorts 1A and 1B)
Description
To be summarized using descriptive statistics
Time Frame
Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
Title
PK parameter of oxaliplatin - Tmax (Cohorts 1A and 1B)
Description
To be summarized using descriptive statistics
Time Frame
Up to 15 days; through Cycle 2, Day 1 (each cycle is 14 days)
Title
Confirmed objective response rate (cORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment (INV) (Cohort 2A)
Description
cORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR)
Time Frame
Up to approximately 2.5 years
Title
Duration of response (DOR) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)
Description
DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression or death from any cause, whichever occurs first.
Time Frame
Up to approximately 2.5 years
Title
Progression-free survival (PFS) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)
Description
PFS is defined as the time from the date of treatment initiation to the date of disease progression or death from any cause, which occurs first.
Time Frame
Up to approximately 2.5 years
Title
Overall survival (OS) (Cohort 1C, 1E, 1F, 1G, and 2A)
Description
OS is defined as the time from treatment initiation to death due to any cause
Time Frame
Up to approximately 2.5 years
Title
Objective response rate (ORR) (Cohorts 1C, 1E, 1F, and 1G)
Description
ORR is defined as the proportion of subjects with confirmed CR or PR, according to RECIST v1.1.
Time Frame
Up to approximately 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below: Cohorts 1A, 1B, 1C, and 1D CRC Gastric adenocarcinoma GEJ adenocarcinoma Esophageal adenocarcinoma Cholangiocarcinoma Gallbladder carcinoma Cohorts 1E, 1F, 1G, and 2A Gastric adenocarcinoma GEJ adenocarcinoma Esophageal adenocarcinoma Cohort 2B CRC Participants must be candidates to receive an oxaliplatin-based regimen as part of their standard-of-care treatment for all cohorts, except Cohort 1G. HER2+ disease, as determined by historic or local laboratory testing Phase 1b cohorts: measurable or non-measurable disease according to RECIST v1.1 as determined by the investigator Phase 2 cohorts: measurable disease according to RECIST v1.1 as determined by the investigator Eastern Cooperative Oncology Group Performance Status score of 0 or 1. Exclusion Criteria: History of known hypersensitivity to planned study treatment Known to be positive for Hepatitis B or C For Cohorts 2A and 2B: prior anti-HER2 therapies For Cohorts 1E, 1F, 1G, 2A: Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) There are additional inclusion criteria. The study center will determine if criteria for participations are met.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seagen Trial Information Support
Phone
8663337436
Email
clinicaltrials@seagen.com
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
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Stanford Cancer Center / Blood and Marrow Transplant Program
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Completed
Facility Name
University of Colorado Hospital / University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Individual Site Status
Completed
Facility Name
Johns Hopkins Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Goldener, RN
Phone
220-660-6500
Email
cgolden9@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Michael Pishvaian
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Completed
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55903-4008
Country
United States
Individual Site Status
Completed
Facility Name
Washington University in St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Wynn
Phone
314-273-4913
Email
wynn@wustl.edu
First Name & Middle Initial & Last Name & Degree
Patrick Grierson
Facility Name
New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Maestas, MD
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melani Terry
Phone
980-442-2000
Email
Melani.terry@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Mohamed E Salem, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Gabrail Cancer Center Research, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Completed
Facility Name
Cleveland Clinic, The
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madilyn Heit
Phone
206-606-6387
Email
mheit@seattlecca.org
First Name & Middle Initial & Last Name & Degree
David B Zhen
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Other
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Other
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
St. Marianna University School of Medicine
City
Kawasaki-shi
State/Province
Other
ZIP/Postal Code
2168511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Other
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Aichi Cancer Center
City
Nagoya-shi
State/Province
Other
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kei Muro
Facility Name
Kindai University Hospital
City
Osakasayama-Shi
State/Province
Other
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka
State/Province
Other
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naotoshi Sugimoto

12. IPD Sharing Statement

Plan to Share IPD
No

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Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

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