Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

Hutchison Medipharma Limited110 enrolled

Overview

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

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 had 54 study sites and enrolled/dosed 110 patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Gastric Cancer Esophagogastric Junction Disorder

Interventions

SavolitinibDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \& 3: 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 4 weeks 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; 3. Received extensive radiotherapy within 4 weeks of treatment 4. Received close distance radiotherapy within 60 days 5. Major surgery within 4 weeks of treatment 6. Taken strong CYP3A4 inducer within 2 weeks 7. Not recovered from past anti-tumor treatment toxicity 8. Active HIV infection 9. Active Hepatitis B or C infection

Locations (1)

Beijing Cancer Hopspital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

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 Outcomes

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

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

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

Time frame: through study completion, an average of 3.5 year

Data from ClinicalTrials.gov

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