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

NCT01335269 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2015-12-09

No results posted yet for this study

Summary

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.

Conditions

  • Neoplasms

Interventions

DRUG

BI 853520

BI 853520 once daily in a dose escalation schedule

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335269 on ClinicalTrials.gov