This Study Aims to Find the Best Dose of BI 907828 in Patients With Different Types of Advanced Cancer (Solid Tumours)

Official Title

A Phase Ia/Ib, Open Label, Multicentre, Dose-escalation Study of BI 907828 in Patients With Advanced or Metastatic Solid Tumours

Summary:

This study is open to adults with different types of advanced cancer (solid tumours). The purpose of this study is to find out the highest dose of BI 907828 the participants can tolerate. In the second part, the study also tests whether BI 907828 makes tumours shrink. In this study, BI 907828 is given to humans for the first time. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. BI 907828 is taken as a tablet. Participants either take a dose of BI 907828 on one day every 3 weeks or on one day in 2 consecutive weeks every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

Trial Description

Primary Outcome:

  • Phase Ia- Maximum tolreated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycle
  • Progression-free survival
  • Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)
  • Phase Ib - Number of patients with DLTs during the first treatment cycle
Secondary Outcome:
  • Phase Ia - Cmax: Maximum measured concentration of BI 907828 in plasma
  • Phase Ia - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
  • Phase Ib - Objective response
  • Phase Ib - Overall survival
  • Phase Ib - Number of patients with Grade ≥3 treatment-related adverse events observed during the entire treatment period
  • Phase Ib - Cmax: Maximum measured concentration of BI 907828 in plasma
  • Phase Ib - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society