Evidence map›Paper›PMID 31769065›Full record

ArticleJournal of clinical pharmacology2020

Population Pharmacokinetics of Glasdegib in Patients With Advanced Hematologic Malignancies and Solid Tumors.

Swan Lin, Naveed Shaik, Giovanni Martinelli, Andrew J Wagner, Jorge Cortes, Ana Ruiz-Garcia

Abstract read
In one paragraph

Article in Journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Therapeutic drug monitoring of oral targeted antineoplastic drugs.European journal of clinical pharmacology · 2021
    Review
  6. Article
  7. Review
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

6 authors.

Swan LinClinical Pharmacology, Global Product Development, Pfizer Inc, San Diego, California, USA.
Naveed ShaikClinical Pharmacology, Global Product Development, Pfizer Inc, San Diego, California, USA.
Giovanni MartinelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST IRCCS), Meldola, Italy.
Andrew J WagnerDana-Farber Cancer Institute, Boston, Massachusetts, USA.
Jorge CortesUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ana Ruiz-GarciaClinical Pharmacology, Global Product Development, Pfizer Inc, San Diego, California, USA.

Funding

Pfizer
6 · The paper itself

Abstract

Glasdegib is an inhibitor of the Hedgehog pathway recently approved in the United States for the treatment of acute myeloid leukemia. A population pharmacokinetic analysis was conducted to characterize the kinetic behavior of glasdegib and its sources of variability (covariates) by utilizing data from 269 patients with cancer treated with oral glasdegib doses ranging from 5 to 640 mg/d. Nonlinear mixed-effects modeling was conducted using NONMEM (v.7.3) and Perl-speaks NONMEM (v.4.2.0). The estimated apparent total clearance, apparent central volume of distribution, and apparent peripheral volume of distribution were 6.27 L/h, 3.32 L, and 279.2 L, respectively. Age, sex, race, and hepatic function were not significant covariates on glasdegib pharmacokinetic parameters. Baseline body weight, percentage bone marrow blasts, creatinine clearance, and use of moderate or strong cytochrome P450 3A inhibitors were statistically significant covariates on apparent total clearance; however, the magnitude of the effects was not considered clinically meaningful.

Indexed as

acute myeloid leukemiaHedgehogmyelodysplastic syndromepopulation pharmacokineticsSmoothened inhibitor

Identifiers

PMID31769065
PMCPMC7187372

What OpenQuestion holds

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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.