Trial reportLeukemia2008
A pilot pharmacokinetic study of oral azacitidine.
Trial report in Leukemia, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04806906 (A Phase 2, Monocentric, Pilot Study to Evaluate Safety and Efficacy of CC 486), which is not on this map. Cited by 33 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Monocentric, Pilot Study to Evaluate Safety and Efficacy of CC 486 (Oral Azacitidine) Plus Best Supportive Care as Maintenance of Response to sc Azacitidine in IPSS Higher Risk Elderly MDS Patients
Who cites it
33 citing papers in PubMed, 68 citations in OpenAlex.
- Oral and intravenous pharmacokinetics of 5-fluoro-2'-deoxycytidine and THU in cynomolgus monkeys and humans.Cancer chemotherapy and pharmacology · 2015Trial
- Myelodysplastic Syndromes: 2026 Update on Diagnosis, Risk-Stratification and Management.American journal of hematology · 2026Review
- Nanotechnology-driven Epigenetic Cancer Therapy: Precision Delivery and Sustained Release of DNA Methylation Modulators.The Yale journal of biology and medicine · 2025Review
- Clinical activity, pharmacokinetics, and pharmacodynamics of oral hypomethylating agents for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: A multidisciplinary review.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2024Review
- Myelodysplastic syndromes: 2023 update on diagnosis, risk-stratification, and management.American journal of hematology · 2023Review
- Review
- Oral hypomethylating agents: beyond convenience in MDS.Hematology. American Society of Hematology. Education Program · 2021Article
- Hypomethylating Chemotherapeutic Agents as Therapy for Myelodysplastic Syndromes and Prevention of Acute Myeloid Leukemia.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Treatment advances for pediatric and adult onset neoplasms with monocytosis.Current hematologic malignancy reports · 2021Review
- Enzyme Models-From Catalysis to Prodrugs.Molecules (Basel, Switzerland) · 2021Review
- Contemporary Risk Stratification and Treatment of Chronic Myelomonocytic Leukemia.The oncologist · 2021Review
- First-in-human study of inhaled Azacitidine in patients with advanced non-small cell lung cancer.Lung cancer (Amsterdam, Netherlands) · 2021Article
- Incorporating novel approaches in the management of MDS beyond conventional hypomethylating agents.Hematology. American Society of Hematology. Education Program · 2017Review
- Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.Future oncology (London, England) · 2016Article
- Oral Azacitidine (CC-486) for the Treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia.The oncologist · 2015Review
- Epigenetics and the overhealing wound: the role of DNA methylation in fibrosis.Fibrogenesis & tissue repair · 2015Article
- Molecular therapeutic approaches for pediatric acute myeloid leukemia.Frontiers in oncology · 2014Review
- Harnessing the potential of epigenetic therapy to target solid tumors.The Journal of clinical investigation · 2014Review
- Epigenetic therapies in MDS and AML.Advances in experimental medicine and biology · 2013Review
- Azacitidine in the management of patients with myelodysplastic syndromes.Therapeutic advances in hematology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
Azacitidine is a pyrimidine nucleoside analog of cytidine with hypomethylating and antileukemia activity. Azacitidine has been shown to have survival benefits in patients with high-risk myelodysplastic syndrome (MDS), and has activity in the treatment of acute myelogenous leukemia (AML). It is administered by subcutaneous (s.c.) or intravenous (i.v.) injection daily at a dose of 75 mg/m(2) for 7 days every 4 weeks. An oral formulation would facilitate dosing, reduce administration side effects and potentially maximize azacitidine pharmacologic action. Previously, oral formulations of this class of agent have failed due to rapid catabolism by cytidine deaminase and hydrolysis in aqueous environments. Development of a film-coated formulation has circumvented this difficulty. In a formulation feasibility pilot study, four subjects with solid malignant tumors, AML or MDS received single oral doses of 60 or 80 mg azacitidine. Subjects demonstrated measurable plasma concentrations of azacitidine, allowing bioavailability comparisons to be made to historical pharmacokinetic data for s.c. azacitidine. Subjects safely tolerated 80 mg, a dose for which the mean bioavailability was 17.4% of historic s.c. exposure. No severe drug-related toxicities were observed. These data suggest that oral azacitidine is bioavailable in humans and should be studied in formal phase 1 trials.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.