Spots Global Cancer Trial Database for Phase I Trial of BI 836845 for Various Solid Cancer
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Trial Identification
Brief Title: Phase I Trial of BI 836845 for Various Solid Cancer
Official Title: A Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Patients With Advanced Solid Cancers With Repeated Administrations in Patients Showing Clinical Benefit
Study ID: NCT01403974
Conditions
Interventions
Study Description
Brief Summary: This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI 836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients. The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
1280.1.88603 Boehringer Ingelheim Investigational Site, Taichung, , Taiwan
1280.1.88602 Boehringer Ingelheim Investigational Site, Tainan, , Taiwan
1280.1.88601 Boehringer Ingelheim Investigational Site, Taipei, , Taiwan
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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