Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

NCT04923932 | Active Not Recruiting Phase 2

• 1 other identifier: 2020-504-00CH1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib

Conditions

Gastric Cancer; Esophagogastric Junction Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (2)

• 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

• incidence of various adverse events (AE)

  through study completion, an average of 3.5 year

Study Arms (1)

Savolitinib

EXPERIMENTAL

GC

Drug: Savolitinib

Interventions

Savolitinib DRUG

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.

Also known as: hmpl-504

Savolitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Beijing Cancer Hopspital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 11, 2021
• Study Start: July 27, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)