Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

Phase 2

Active, not recruiting

• Conditions: Gastric Cancer; Esophagogastric Junction Disorder
• Interventions: Drug: Savolitinib

• Registration Number: NCT04923932
• Lead Sponsor: Hutchison Medipharma Limited

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

Study Timeline

• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Study Start: 2021-07-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
2. Age ≥18 years;
3. Histologically diagnosed locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma
4. MET gene amplifications
5. Cohort 1: Having measurable lesions (in accordance with RECIST 1.1 criteria); Cohort 2: having evaluable lesions
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
7. Survival is expected to exceed 12 weeks;
8. Adequate functionality in bone marrow, liver, kidney
9. Able to take or swallow the drug orally.
10. 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

1. 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;
2. 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Savolitinib	Savolitinib	GC

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)	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	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

Name	Time	Method
Progression-free survival (PFS) (RECIST 1.1 criteria)	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	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)	through study completion, an average of 3.5 year	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

Trial Locations

Locations (1)

Beijing Cancer Hopspital; 🇨🇳 Beijing, Beijing, China