Neoplasms Clinical Trial
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
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).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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