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Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04923932
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
Hutchmed ( Hutchison Medipharma Limited )

Study Description
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Brief Summary:
Treating Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications with Savolitinib

Condition or disease Intervention/treatment Phase
Gastric Cancer Esophagogastric Junction Disorder Drug: Savolitinib Phase 2

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 is planned that about 30 study sites will enroll 75 patients
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Phase II Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Savolitinib in Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients With MET Gene Amplifications
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Savolitinib
GC
 Drug: Savolitinib
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.
Other Name: hmpl-504


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 Outcome Measures :
  1. Progression-free survival (PFS) (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 ]
    Efficacy of Savolitinib in the treatment of locally advanced or metastatic Gastric Cancer and Esophagogastric junction adenocarcinoma Patients with MET gene amplifications

  2. incidence of various adverse events (AE) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923932


Contacts
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Contact: Tinghua Song 19512230542 tinghuas@hutch-med.com

Locations
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China, Beijing
Beijing Cancer Hopspital Recruiting
Beijing, Beijing, China
Contact: Lin Shen         
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Lin Shen, MD Peking University Cancer Hospital & Institute
More Information
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT04923932    
Other Study ID Numbers: 2020-504-00CH1
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases