Trial Profile
A phase 2 study of decitabine administered daily for 5 days every 4 weeks to adults with advanced-stage myelodysplastic syndromes
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 03 Nov 2021
Price :
$35
*
At a glance
- Drugs Decitabine (Primary)
- Indications Myelodysplastic syndromes
- Focus Registrational; Therapeutic Use
- Acronyms ADOPT
- Sponsors Eisai Inc
- 11 Dec 2018 A population pharmacokinetic model was developed by pooling decitabine concentration-time data from 5 adult (AML and MDS) and 2 pediatric (AML) studies (DACO-018, DACO-017, DACO-020, DACO-016, E7373-A001-101, E7373-G000-202 and DACOGENAML2004 trial); results published in the Journal of Clinical Pharmacology
- 11 Mar 2010 Results from this trial were used to support US FDA approval of the 5-day decitabine regimen in patients with myelodysplastic syndromes, as reported by Eisai.
- 09 Sep 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.