Spots Global Cancer Trial Database for This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer
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Trial Identification
Brief Title: This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer
Official Title: An Open Label, Phase I Study of BI 754091 Monotherapy and Combination Therapy of BI 754091 and BI 754111 in Asian Patients With Advanced Solid Tumours
Study ID: NCT03433898
Conditions
Study Description
Brief Summary: The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are to investigate the following items in advanced solid tumours: * Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy. * Maximum tolerated dose (MTD) and/or recommended dose (RD) of BI 754091 monotherapy. The main objectives of the Combination dose-finding part (Part II) of the trial are to investigate the following items in advanced solid tumours: * Safety, tolerability, and PK of the combination treatment of BI 754091 and BI 754111. * MTD and/or RD of the combination treatment of BI 754091 and BI 754111. The main objectives of the expansion part (Part III) of the trial are: * To further investigate the safety, tolerability, and PK of the RD of BI 754091 and BI 754111 combination in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or non-small cell lung cancer (NSCLC) * To explore the efficacy of the RD of the combination of BI 754091 and BI 754111 in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or NSCLC
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
Kanagawa Cancer Center, Kanagawa, Yokohama, , Japan
Saitama Cancer Center, Saitama, Kitaadachi-gun, , Japan
Shizuoka Cancer Center, Shizuoka, Sunto-gun, , Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
Japanese Foundation for Cancer Research, Tokyo, Koto-ku, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
NCKUH, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital(Linkou), TaoYuan, , Taiwan
Contact Details
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