A phase 1/2 dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics and preliminary efficacy of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) as monotherapy in patients with advanced solid tumours or in combination with nintedanib in patients with non-small cell lung cancer (NSCLC)
Phase of Trial: Phase I/II
Latest Information Update: 15 Nov 2018
At a glance
- Drugs Docetaxel (Primary) ; Nintedanib
- Indications Adenocarcinoma; Non-small cell lung cancer; Solid tumours
- Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
- Sponsors Starpharma
- 08 Nov 2018 Planned number of patients changed from 45 to 65.
- 23 May 2018 Planned number of patients changed from 16 to 45.
- 25 Jan 2018 According to a Starpharma media release, University College London Hospital (UCLH) Cancer Clinical Trials Unit has been initiated for the phase 2 and is expected to commence recruitment shortly. Two further sites in the UK are also in the process of being initiated.