Study of AZD6094 (Volitinib) in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Third-line Treatment
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|ClinicalTrials.gov Identifier: NCT02449551|
Recruitment Status : Recruiting
First Posted : May 20, 2015
Last Update Posted : January 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Adenocarcinoma||Drug: Volitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||February 10, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Volitinib 800 mg will be administered orally once a day for 21 days as one cycle.
Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor. Volitinib 800 mg will be administered orally once a day for 21 days as one cycle.
Other Name: AZD6094
- Progression-free survival (PFS) [ Time Frame: 8 weeks ]
- Objective response rate (ORR) [ Time Frame: 8 weeks ]
- Duration of response [ Time Frame: 8 weeks ]
- Disease control rate [ Time Frame: 8 weeks ]
- Overall survival (OS) [ Time Frame: 8 weeks ]
- Number of subjects with Adverse Events as a measure of safety and tolerability [ Time Frame: 8 weeks ]
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): NCT02449551
|Contact: yoon jeong Ahn||221487395 ext 82|
|Contact: Jee yun Lee, MD,Ph.D.||234103459 ext 82|
|Korea, Republic of|
|Samsung Medical center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Yoonjeong Ahn 82-2-2148-7395 email@example.com|
|Principal Investigator: Jeeyun Lee, MD,PhD|
|Principal Investigator:||Jee yun Lee, MD,Ph.D.||Samsung Medical Center,Seoul,Korea|