Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients
Primary Purpose
Gastric Cancer, Esophagogastric Junction Disorder
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Savolitinib
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
- Age ≥18 years;
- Histologically diagnosed locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma
- MET gene amplifications
- Cohort 1: Having measurable lesions (in accordance with RECIST 1.1 criteria); Cohort 2: having evaluable lesions
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Survival is expected to exceed 12 weeks;
- Adequate functionality in bone marrow, liver, kidney
- Able to take or swallow the drug orally.
- Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 30 days after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug;
Exclusion Criteria:
- Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled;
- Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment;
Sites / Locations
- Beijing Cancer HopspitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Savolitinib
Arm Description
GC
Outcomes
Primary Outcome Measures
Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
Secondary Outcome Measures
Progression-free survival (PFS) (RECIST 1.1 criteria)
Efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
incidence of various adverse events (AE)
To evaluate the safety and tolerability of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
Full Information
NCT ID
NCT04923932
First Posted
May 30, 2021
Last Updated
March 29, 2023
Sponsor
Hutchison Medipharma Limited
1. Study Identification
Unique Protocol Identification Number
NCT04923932
Brief Title
Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients
Official Title
A Multi-center, Open-label, Phase II Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Savolitinib in Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients With MET Gene Amplifications
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchison Medipharma Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib
Detailed Description
This is a single-arm, multi-cohort, multi-center, open-label, phase II clinical study. The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications. The study involves a Screening Period, a Treatment Period and a Follow-up Period. It is planned that about 30 study sites will enroll 75 patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Esophagogastric Junction Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with measurable lesions OR with no measurable lesions but have evaluable lesions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Savolitinib
Arm Type
Experimental
Arm Description
GC
Intervention Type
Drug
Intervention Name(s)
Savolitinib
Other Intervention Name(s)
hmpl-504
Intervention Description
Patients meeting the study inclusion criteria will receive Savolitinib [Savolitinib 600 mg, po, once per day (QD) continuously in patients with baseline weight ≥50 kg, and Savolitinib 400 mg, po, QD in patients with baseline weight <50 kg] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest.
Primary Outcome Measure Information:
Title
Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
Description
To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) (RECIST 1.1 criteria)
Description
Efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months
Title
incidence of various adverse events (AE)
Description
To evaluate the safety and tolerability of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications
Time Frame
through study completion, an average of 3.5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
Age ≥18 years;
Histologically diagnosed locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma
MET gene amplifications
Cohort 1: Having measurable lesions (in accordance with RECIST 1.1 criteria); Cohort 2: having evaluable lesions
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
Survival is expected to exceed 12 weeks;
Adequate functionality in bone marrow, liver, kidney
Able to take or swallow the drug orally.
Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 30 days after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug;
Exclusion Criteria:
Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled;
Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tinghua Song
Phone
19512230542
Email
tinghuas@hutch-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hopspital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients
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