Clinical Trials Logo

Clinical Trial Summary

Phase Ib/II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in advanced gastric adenocarcinoma patients with MET amplification as a second-line treatment. Phase Ib:Investigational product, dosage and mode of administration Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor. Volitinib should be administered at least 200mg orally once a day in 21 days for achieving appropriate antitumor activity. Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks Phase II: Investigational product, dosage and mode of administration Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor. Subjects will receive Volitinib once daily ( at the MTD determined from Phase Ib) for 21 days as one cycle. Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.


Clinical Trial Description

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. In a xenograft model Hs746T with c-Met gene amplification, suboptimal doses 0.6 mg/kg volitinib and 3 mg/kg docetaxel induced TGI(expand) of 55.8% and 80.8%, respectively, whereas combination resulted in a TGI by 101.1%, and statistical significance was seen between combination group and either of mono-therapy group. Plasma exposures of volitinib and docetaxel were determined after last dose at the end of study, and there was no significant difference between combination and single agent on exposures of either volitinib or docetaxel. More importantly, combination was well tolerant and no body weight loss was found in the animals. These results suggested that it would be worthwhile to study the combination use of volitinib and docetaxel in clinic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02447406
Study type Interventional
Source Samsung Medical Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 30, 2015
Completion date September 20, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04977193 - A Study to Evaluate the Safety and Efficacy of ly011 Cell Injection in the Treatment of Advanced Gastric Adenocarcinoma Early Phase 1
Recruiting NCT04993378 - Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy
Recruiting NCT05583383 - A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab N/A
Completed NCT06238752 - First-line Apatinib Combined With Tislelizumab and Chemotherapy for Advanced GC Phase 2
Recruiting NCT04209686 - Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma Phase 2
Recruiting NCT02240524 - Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer Phase 3
Completed NCT02447380 - Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Advanced Gastric Adenocarcinoma Patients With MET Overexpression as a Second-line Treatment Phase 2
Recruiting NCT06203600 - Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial Phase 2/Phase 3
Recruiting NCT05677490 - mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma Phase 3
Completed NCT02448329 - Study of AZD1775 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring TP53 Mutation as a Second-line Chemotherapy Phase 2
Completed NCT02615730 - PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma Phase 1/Phase 2
Recruiting NCT05041153 - Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma Early Phase 1
Terminated NCT02449655 - Trial of AZD5363 Plus Paclitaxel /AZD2014 Plus Paclitaxel in Biomarker Negative (PIK3CA/MEK/RAS/TP53/MET) Gastric Adenocarcinoma Patients as Second-line Chemotherapy Phase 2
Completed NCT02449551 - Study of AZD6094 (Volitinib) in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Third-line Treatment Phase 2
Not yet recruiting NCT04174339 - PD-1 Antibody(SHR-1210) Plus Apatinib Combined With POF in Advanced Gastric Cancer N/A
Completed NCT02599324 - Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors Phase 1/Phase 2
Recruiting NCT06028737 - Total Neoadjuvant Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer Phase 2/Phase 3
Recruiting NCT04675866 - Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer N/A
Recruiting NCT03159819 - Clinical Study of CAR-CLD18 T Cells in Patients With Advanced Gastric Adenocarcinoma and Pancreatic Adenocarcinoma N/A