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Clinical Trial Summary

Single-agent, open-label, multi-center sequential dose escalation and expansion study of BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced or recurrent solid tumors or recurrent glioblastoma.

Clinical Trial Description

This is the first study of prolonged intravenous infusion of BAL101553. BAL101553 will be administered as an intravenous infusion over 48 hours, to adults with advanced or recurrent solid tumors or recurrent glioblastoma who have failed standard therapy, or for whom no effective standard therapy is available.

The primary goal of the study is to find the highest dose of BAL101553 that can safely be given to humans and to assess what side effects occur. The study will start by treating patients with a low dose. Once it has been shown that this low dose is well tolerated, new patients will be treated at higher dose levels ("dose escalation"). Once the highest, well tolerated dose is identified, 20 new patients with platinum-resistant/refractory ovarian cancer and 20 new patients with recurrent glioblastoma will be treated at that dose (this part is called "dose expansion") to further assess the tolerability and potential anticancer activity of oral BAL101553. The study will also measure pharmacokinetics, pharmacodynamic effects and assess biomarkers. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02895360
Study type Interventional
Source Basilea Pharmaceutica
Contact Thomas Kaindl, MD
Phone +41 61 567 1505
Status Recruiting
Phase Phase 1/Phase 2
Start date August 2016
Completion date September 2019

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