Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

Sponsor
Hutchison Medipharma Limited
Study ID
NCT04923932
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Jul 27, 2021
Status verified
May 2026
Primary completion
Apr 21, 2026
Completion
Apr 21, 2026

Study Design

Enrollment
110 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib
    GC

Primary Outcome Measure

Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria) [ 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 ]

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