Phase
Condition
Digestive System Neoplasms
Gastric Cancer
Adenocarcinoma
Treatment
Savolitinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Fully aware this study and signed the informed consent form in voluntary manner, andwilling and able to comply with the study procedure;
Age ≥18 years;
Histologically diagnosed locally advanced or metastatic Gastric Cancer andEsophagogastric junction adenocarcinoma
MET gene amplifications
Cohort 1 & 3: 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 contraceptivemethods from screening period to 4 weeks after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must usecondom during sexual intercourse during the study and within 6 months afterdiscontinuation of study drug;
Exclusion
Exclusion Criteria:
Currently having other malignant tumors, or having other infiltrating malignanttumors in the past 5 years. Stage I malignant tumor after radical treatment for atleast 3 years, except those considered by investigators to have small possibility ofrecurrence. Patients with radically treated carcinoma in situ (non-infiltrating) andskin 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 treatmentwith small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeksprior to the start of study treatment;
Received extensive radiotherapy within 4 weeks of treatment
Received close distance radiotherapy within 60 days
Major surgery within 4 weeks of treatment
Taken strong CYP3A4 inducer within 2 weeks
Not recovered from past anti-tumor treatment toxicity
Active HIV infection
Active Hepatitis B or C infection
Study Design
Study Description
Connect with a study center
Beijing Cancer Hopspital
Beijing, Beijing Municipality
ChinaSite Not Available

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