Pancreatic Cancer Research

Clinical trialPhase 1Completed

A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer

An Open Label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Patients With Various Advanced or Metastatic Non-hematologic Malignancies

NCT01335269↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Finished, no results posted
Phase
Phase 1
Status
Completed
Study type
Interventional
Start
July 2011
Expected end
December 2015
Enrollment
96 participants
Sites
5
Primary outcomes
Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient in the dose finding phase
Sponsor
Industry
Results posted
No
Last update
9 December 2015

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Brief summary public domain (ClinicalTrials.gov)

The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound. Secondary objectives are * determination of the pharmacokinetic (PK) profile; * exploratory pharmacodynamic analysis; and * collection of preliminary data on anti-tumour efficacy.

Papers 3