A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
Phase of Trial: Phase I
Latest Information Update: 29 Dec 2017
At a glance
- Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Venetoclax (Primary)
- Indications Myelodysplastic syndromes
- Focus Adverse reactions; Pharmacokinetics
- Sponsors AbbVie
- 21 Dec 2017 Planned number of patients changed from 56 to 44.
- 31 Oct 2017 Planned number of patients changed from 44 to 56.
- 26 Sep 2017 Phase of the trial has been changed from Phase II to Phase I; Efficacy endpoints have been removed and trial focus changed to only PK and AR; Planned number of patients changed from 90 to 44.