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Trastuzumab, Bevacizumab With Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)

Primary Purpose

HER2-positive Advanced Gastric Cancer

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
trastuzumab, bevacizumab with paclitaxel (triple combination)
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2-positive Advanced Gastric Cancer focused on measuring HER2-positive gastric cancer, trastuzumab, bevacizumab & paclitaxel

Eligibility Criteria

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

Inclusion Criteria: HER2-positive advanced gastric cancer Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal ≥ 2.0) or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring) Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer Patients who are willing and able to write a written consent form for this trial. Patients aged 19 years or older at the time of signing the subject consent form. Patients with measurable or evaluable lesions according to RECIST 1.1. ECOG activity status 0, 1 or 2 as patients with adequate organ function Absolute neutrophil (ANC) ≥1.0 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥9 g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN Echocardiogram EF ≥55% or MUGA scan ≥50% Exclusion Criteria: Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks. Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months Patients who have experienced an arteriovascular embolism event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or any other serious medical disorder not controlled in the investigator's judgment patient with Patients with a history of gastrointestinal perforation or fistula within 6 months. Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervical cancer

Sites / Locations

  • Kangbuk Samsung HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TREAZURE

Arm Description

This is a single arm study. Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.

Outcomes

Primary Outcome Measures

Progression-free survival
Defined as the time from the start of treatment to the date of documented disease progression (according to RECIST 1.1) or death from any cause.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2022
Last Updated
March 7, 2023
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05640830
Brief Title
Trastuzumab, Bevacizumab With Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy
Acronym
TREAZURE
Official Title
A Phase 1B/2 Study of Trastuzumab, Bevacizumab With Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.
Detailed Description
Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Advanced Gastric Cancer
Keywords
HER2-positive gastric cancer, trastuzumab, bevacizumab & paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TREAZURE
Arm Type
Experimental
Arm Description
This is a single arm study. Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.
Intervention Type
Drug
Intervention Name(s)
trastuzumab, bevacizumab with paclitaxel (triple combination)
Intervention Description
Trastuzumab 4 mg/kg Day 1, 15 Bevacizumab 5 mg/kg Day 1, 15 Paclitaxel 80 mg/m2 Day 1, 8, 15 every 4 weeks
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Defined as the time from the start of treatment to the date of documented disease progression (according to RECIST 1.1) or death from any cause.
Time Frame
up to 36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HER2-positive advanced gastric cancer Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal ≥ 2.0) or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring) Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer Patients who are willing and able to write a written consent form for this trial. Patients aged 19 years or older at the time of signing the subject consent form. Patients with measurable or evaluable lesions according to RECIST 1.1. ECOG activity status 0, 1 or 2 as patients with adequate organ function Absolute neutrophil (ANC) ≥1.0 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥9 g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN Echocardiogram EF ≥55% or MUGA scan ≥50% Exclusion Criteria: Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks. Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months Patients who have experienced an arteriovascular embolism event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or any other serious medical disorder not controlled in the investigator's judgment patient with Patients with a history of gastrointestinal perforation or fistula within 6 months. Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervical cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Hoe Koo, MD,PhD
Phone
+82-2-2001-8330
Email
dhkoo.smc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Hoe Koo, MD,PhD
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Hoe Koo, MD,PhD
Phone
+82-2-2001-8330
Email
d.h.koo@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Trastuzumab, Bevacizumab With Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy

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