Evidence map›Paper›PMID 33493392›Full record

ArticleClinical and translational science2021

Population pharmacokinetic and exposure-response analyses of ivosidenib in patients with IDH1-mutant advanced hematologic malignancies.

Xuemin Jiang, Russ Wada, Bill Poland, Huub Jan Kleijn, Bin Fan, Guowen Liu, Hua Liu, Stephanie Kapsalis, Hua Yang, Kha Le

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Ivosidenib: IDH1 Inhibitor for the Treatment of Acute Myeloid Leukemia.Journal of the advanced practitioner in oncology · 2019
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Xuemin JiangAgios Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
Russ WadaCertara, Menlo Park, California, USA.
Bill PolandCertara, Menlo Park, California, USA.
Huub Jan KleijnCertara, Menlo Park, California, USA.
Bin FanAgios Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
Guowen LiuAgios Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
Hua LiuAgios Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
Stephanie KapsalisAgios Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
Hua YangAgios Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
Kha LeAgios Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
Agios Pharmaceuticals (United States) · USCertara (United States) · USMenlo School · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ivosidenib is a once daily (q.d.), orally available, potent mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor approved for treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and intensive chemotherapy ineligible AML with a susceptible IDH1 mutation. Population pharmacokinetics (PKs; N = 253), exposure-response (efficacy [n = 201] and safety [n = 253]), and concentration-corrected electrocardiogram QT interval (QTc; n = 171) analyses were performed using phase I data (100 mg twice daily and 300-1200 mg q.d.). Ivosidenib disposition was well-described by a two-compartment PK model with first-order absorption and elimination. Between-subject variability was moderate for PK parameters. Intrinsic factors did not affect ivosidenib PKs. Moderate/strong CYP3A4 inhibitors increased the area under the plasma ivosidenib concentration-time curve at steady state (AUC

Indexed as

Administration, OralAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsArea Under CurveBiological Variation, PopulationCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsDrug InteractionsElectrocardiographyFemaleGlycineHumansIsocitrate DehydrogenaseAntineoplastic AgentsCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InhibitorsGlycineIDH1 protein, humanIsocitrate DehydrogenaseivosidenibPyridines

Identifiers

PMID33493392
PMCPMC8212730
OpenAlexW3123651342

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.