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Study of AZD6094 (Volitinib) in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Third-line Treatment | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of AZD6094 (Volitinib) in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Third-line Treatment

NCT02449551•Samsung Medical Center

View on ClinicalTrials.gov

Summary

Volitinib is a potent and selective small molecule c-Met kinase inhibitor. Volitinib was found to inhibit c-Met kinase at the enzyme and cell levels with IC50s of 4 nM for both enzyme and Met phosphorylation in the cell. Consistent with its potent enzyme and cell activity, volitinib was found to inhibit cell growth in vitro against tumors with c-Met gene amplification in the absence of HGF stimulation with IC50s generally below 10 nM. It also potently inhibited HGF-stimulated cell proliferation against tumors with c-Met overexpression or carrying a HGF/c-Met autocrine loop. This study is a single-arm, phase II study of votilinib in patients with advanced gastric adenocarcinoma harboring MET amplification as a third line treatment Volitinib 800 mg will be administered orally once a day for 21 days as one cycle. To investigate the efficacy of volitinib in patients with advanced gastric adenocarcinoma harboring MET amplification.

Detailed Description

same as above

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of fully informed consent prior to any study specific procedures.
•2. Patients must be ≥20 years of age.
•3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second-line therapy.
•* Both fluoropyrimidine and platinum agent need to be contained in the prior chemotherapies
•* Prior adjuvant or neoadjuvant therapy is counted as 1 regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy.
•4. Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
•5. Patients with MET amplification.
•6. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
•7. Eastern Cooperative Oncology Group performance status 0-1.
•8. Patients must have a life expectancy ≥ 3 months from proposed first dose date.
+12 more criteria

Exclusion Criteria

•1. Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
•2. Any previous treatment with MET inhibitors
•3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
•4. HER2 positive patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)
•5. Patients unable to swallow orally administered medication.
•6. Treatment with any investigational product during the last 21 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).
•7. Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denusomab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
•8. With the exception of alopecia, any ongoing toxicities (\>Common Toxicity Criteria for Adverse Effects grade 1) caused by previous cancer therapy.
•9. Intestinal obstruction or Common Toxicity Criteria for Adverse Effects grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
•10. Resting ECG with measurable QTcB \> 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
+4 more criteria

Locations (1)

Samsung Medical center

Seoul, South Korea

Key Dates

Start Date

February 10, 2016

Primary Completion Date

December 30, 2020

Completion Date

August 27, 2021

Last Updated

June 15, 2022

Enrollment

ACTUAL participants

Conditions

Advanced Gastric Adenocarcinoma

Interventions

Volitinib

DRUG

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RECRUITINGEARLY_PHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of AZD6094 (Volitinib) in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Third-line Treatment

Inclusion Criteria

Exclusion Criteria

mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma

Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma

Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma

Phase Ib, Single-arm Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Any Solid Cancer and Sequential Phase II, Single-arm Study of AZD6094 (Volitinib) in Combination With Docetaxel in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Second Line Treatment

Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer

Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy