Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

Launched by HUTCHISON MEDIPHARMA LIMITED · Jun 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Savolitinib to see how well it works for patients with gastric cancer and esophagogastric junction adenocarcinoma, especially those who have a specific change in their genes known as MET gene amplifications. The trial is currently looking for participants who are at least 18 years old and have been diagnosed with either locally advanced or metastatic gastric cancer. To join, individuals must be able to take the medication orally and have a good level of overall health, as determined by a performance status scale.

Participants in the trial will receive Savolitinib and will be monitored for its effectiveness and any side effects. This is a Phase 2 trial, which means it’s focused on evaluating how well the treatment works after initial safety has been established. It’s important for potential participants to understand that they should not have other active cancers and should not have received certain cancer treatments within a specified time frame before starting the trial. If you or someone you know is interested in participating, it's essential to discuss this with a healthcare provider to ensure eligibility and understand what to expect.

Gender

ALL

Eligibility criteria

• 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: 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 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;
• 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;