A Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Dosimetry, Maximum Tolerated Dose and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by Systemic IV Administration of Escalating Doses of [177Lu]DOTA-biotin in Patients With Liver Metastases From Colorectal Cancer
Phase of Trial: Phase I
Latest Information Update: 19 Jun 2017
At a glance
- Drugs AvidinOx-Lu-177-DOTA-Biotin (Primary) ; Lutetium-177 biotin-DOTA (Primary)
- Indications Liver metastases
- Focus Adverse reactions
- Sponsors sigma-tau SpA
- 13 Jun 2017 Planned End Date changed from 1 Mar 2018 to 1 Dec 2018.
- 13 Jun 2017 Planned primary completion date changed from 1 Dec 2017 to 1 Feb 2018.
- 06 Apr 2016 Planned End Date changed from 1 Jun 2017 to 1 Mar 2018 as reported by ClinicalTrials.gov record.