NCT01519011 is a Phase 1 clinical trial of oral azacitidine in Myelodysplastic Syndromes, sponsored by Celgene.

Who is sponsoring NCT01519011?

NCT01519011 is sponsored by Celgene.

What drugs are being tested in NCT01519011?

Interventions in NCT01519011: oral azacitidine, oral azacitidine.

What condition does NCT01519011 study?

NCT01519011 studies Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute.

Is NCT01519011 still recruiting?

NCT01519011 is currently completed. Last updated 12 November 2019.

Last reviewed 2019-11-12 · How we verify

NCT01519011

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine

Completed Phase 1 Last updated 12 November 2019

What this trial tests

Phase 1 trial testing oral azacitidine in Myelodysplastic Syndromes in 34 participants. Completed in 12 May 2015.

Timeline

7 February 2012

Primary endpoint
31 December 2012

12 May 2015

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	7 February 2012
Primary completion	31 December 2012
Estimated completion	12 May 2015
Sites	8 locations across United States

Drugs / interventions tested

oral azacitidine
oral azacitidine

Conditions studied

Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
Leukemia, Myelomonocytic, Chronic — all drugs for Leukemia, Myelomonocytic, Chronic →
Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Myelodysplastic Syndromes or Leukemia, Myelomonocytic, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg tablets relative to three 100-mg tablets.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Extended dosing with CC-486 (oral azacitidine) in patients with myeloid malignancies.
Savona MR, Kolibaba K, Conkling P, Kingsley EC, et al · · 2018 · cited 43× · PMID 30016552 · DOI 10.1002/ajh.25216
Epimutational profile of hematologic malignancies as attractive target for new epigenetic therapies.
Fratta E, Montico B, Rizzo A, Colizzi F, et al · · 2016 · cited 17× · PMID 27329599 · DOI 10.18632/oncotarget.10033
Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.
Babiker HM, Milhem M, Aisner J, Edenfield W, et al · · 2020 · cited 5× · PMID 32036412 · DOI 10.1007/s00280-020-04037-9

Verify or expand the search:

Other trials of oral azacitidine

Trials testing the same drug.

NCT01845805 — Trial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine) · Phase 2 · completed

Other recruiting trials for Myelodysplastic Syndromes

Currently open trials in the same condition.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06303193 — Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or · Phase 1, PHASE2 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
NCT07283900 — Ascorbate in Myelodysplastic Syndrome · Phase 2 · recruiting
NCT06487247 — HEME Home Transfusion Program · NA · recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01519011 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 12 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01519011.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing