Evidence map›Paper›PMID 32036412›Full record

ArticleCancer chemotherapy and pharmacology2020

Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.

Hani M Babiker, Mohammed Milhem, Joseph Aisner, William Edenfield, Dale Shepard, Michael Savona, Swaminathan Iyer, Maen Abdelrahim, C L Beach, Barry Skikne and 3 more

Erratum issuedOpen access · hybridAbstract read
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 32% of its field
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 1 country.

Hani M BabikerUniversity of Arizona Comprehensive Cancer Center, Tucson, AZ, USA. hanibabiker@email.arizona.edu.ORCID http://orcid.org/0000-0002-9368-6296
Mohammed MilhemUniversity of Iowa Hospital, Iowa City, IA, USA.
Joseph AisnerRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
William EdenfieldGreenville Health System, Greenville, SC, USA.
Dale ShepardCleveland Clinic, Cleveland, OH, USA.
Michael SavonaVanderbilt University Medical Center, Nashville, TN, USA.
Swaminathan IyerMD Anderson Cancer Center, Houston, TX, USA.
Maen AbdelrahimHouston Methodist Hospital, Houston, TX, USA.
C L BeachCelgene Corporation, Summit, NJ, USA.
Barry SkikneCelgene Corporation, Summit, NJ, USA.
Eric LailleCelgene Corporation, Summit, NJ, USA.
Kao-Tai TsaiCelgene Corporation, Summit, NJ, USA.
Thai HoMayo Clinic, Phoenix, AZ, USA.
Cleveland Clinic · USMayo Clinic Hospital · USMethodist Hospital · USPrisma Health · USRutgers, The State University of New Jersey · USThe University of Texas MD Anderson Cancer Center · USUniversity of Arizona · USUniversity of Iowa · USUniversity of Kansas Medical Center · USVanderbilt University Medical Center · US

Funding

Deciphering the interplay between H3K36 and DNA methylation in renal cancerR01CA224917 · NCI · MAYO CLINIC ROCHESTER · PI HO, THAI HUU, ROBERTSON, KEITH D · 2018 to 2022
$2.9M
NCI NIH HHS R01 CA224917
6 · The paper itself

Abstract

purposeCC-486 is an oral formulation of azacitidine that allows for extended dosing schedules to prolong azacitidine exposure to malignant cells and maximize clinical activity. CC-486 300 mg daily, administered for 14 or 21 days of 28-day treatment cycles, is currently under investigation in two ongoing phase III trials. The 300-mg daily dose in these studies is administered as two 150-mg tablets (Formulation A).

methodsWe evaluated the bioequivalence of one 300-mg CC-486 tablet (Formulation B) with Formulation A and food effect on Formulation B, in adult patients with cancer in a 2-stage crossover design study.

resultsThe ratios of the geometric means of the maximum azacitidine plasma concentration (C

conclusionThe single 300-mg CC-486 tablet was bioequivalent to two 150-mg tablets, which have shown to be efficacious and generally well-tolerated in clinical trials, and can be taken with or without food.

Indexed as

BioequivalenceCC-486Oral azacitidinePharmacokinetics

Identifiers

PMID32036412
PMCPMC7036073
OpenAlexW3004570383

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.