An Open Label, Phase I Study to Assess the Effect of Itraconazole (CYP3A4 and P-gp Inhibitor) on the Pharmacokinetics of Anetumab Ravtansine and to Assess the ECG Effects, Safety and Immunogenicity of Anetumab Ravtansine Given as a Single Agent and Together With Itraconazole in Subjects With Mesothelin-expressing Advanced Solid Cancers
Phase of Trial: Phase I
Latest Information Update: 26 Nov 2017
At a glance
- Drugs Anetumab ravtansine (Primary) ; Itraconazole
- Indications Solid tumours
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Bayer
- 18 Sep 2017 Planned number of patients changed from 48 to 61.
- 18 Sep 2017 Planned primary completion date changed from 25 May 2018 to 31 Oct 2018.
- 31 Jul 2017 Planned primary completion date changed from 22 Mar 2018 to 25 May 2018.