Spots Global Cancer Trial Database for PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
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Trial Identification
Brief Title: PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer
Official Title: A Phase IB, Multicenter, Open-label Dose Escalation Study of the PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer Carrying a Molecular Alteration of PIK3CA or an Amplification of HER2
Study ID: NCT01613950
Study Description
Brief Summary: The study is intended to investigate the safety of BYL719 and AUY922 in patients with advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination. In addition, the preliminary efficacy of BYL719 in combination with AUY922, and the pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study, if their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2. The study includes a dose escalation part followed by a safety expansion phase.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Massachusetts General Hospital Mass General 2, Boston, Massachusetts, United States
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology, Houston, Texas, United States
Novartis Investigative Site, Köln, , Germany
Novartis Investigative Site, Würzburg, , Germany
Novartis Investigative Site, Chuo-ku, Tokyo, Japan
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Bellinzona, , Switzerland
Novartis Investigative Site, Taipei, , Taiwan
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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