Esophagogastric Junction Disorder, Gastric Cancer
Conditions
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 had 54 study sites and enrolled/dosed 110 patients.
Interventions
DRUGSavolitinib
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.
Sponsors
Hutchison Medipharma Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLin Shen, MD
Peking University Cancer Hospital & Institute
Outcome results
None listed