Completed PHASE1 INTERVENTIONAL 2-arm NCT00528983

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia

A Phase 1, Open-label, Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML).

Sponsor: Celgene

Conditions Acute Myelogenous Leukemia (AML) Chronic Myelomonocytic Leukemia (CMML) Myelodysplastic Syndromes (MDS)

Interventions Oral Azacitidine Subcutaneous (SC) Azacitidine

Updated 7 times since 2017 Last updated: Nov 6, 2019 Started: Sep 11, 2007 Primary completion: Jul 31, 2013 Completion: Apr 5, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00528983, this PHASE1 trial focuses on Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML) and remains completed. Sponsored by Celgene, it has been updated 7 times since 2007, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Dec 2019 — Jan 2021 [monthly]

Completed PHASE1
Jun 2018 — Dec 2019 [monthly]

Completed PHASE1

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Sep 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Celgene

Data source: Celgene

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Austin, United States , Baltimore, United States , Canton, United States , Chicago, United States , Gainesville, United States , Greenville, United States , Houston, United States , Indianapolis, United States , Kansas City, United States and 8 more locations