Evidence map›Paper›PMID 20160731›Full record

ArticleBritish journal of cancer2010

Population pharmacokinetics of the humanised monoclonal antibody, HuHMFG1 (AS1402), derived from a phase I study on breast cancer.

B Royer, W Yin, M Pegram, N Ibrahim, C Villanueva, D Mir, F Erlandsson, X Pivot

Abstract read
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Article in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Pharmacokinetics and Biodistribution of a [Molecular pharmaceutics · 2019
    Article
  5. Article
  6. 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

8 authors.

B RoyerCHU Besançon, Laboratoire de Pharmacologie Clinique, Hôpital Jean Minjoz, Besançon, France. broyer@chu-besancon.fr
W Yin
M Pegram
N Ibrahim
C Villanueva
D Mir
F Erlandsson
X Pivot

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuHMFG1 (AS1402) is a humanised monoclonal antibody that has undergone a phase I trial in metastatic breast cancer. The aim of this study was to characterise the pharmacokinetics (PKs) of HuHMFG1 using a population PK model.

methodData were derived from a phase I study of 26 patients receiving HuHMFG1 at doses ranging from 1 to 16 mg kg(-1). Data were analysed using NONMEM software and covariates were included. A limited sampling strategy (LSS) was developed using training and a validation data set.

resultsA linear two-compartment model was shown to be adequate to describe data. Covariate analysis indicated that weight was not related to clearance. An LSS was successfully developed on the basis of the model, in which one sample is collected immediately before the start of an infusion and the second is taken at the end of infusion.

conclusionA two-compartment population PK model successfully describes HuHMFG1 behaviour. The model suggests using a fixed dose of HuHMFG1, which would simplify dosing. The model could be used to optimise dose level and dosing schedule if more data on the correlation between exposure and efficacy become available from future studies. The derived LSS could optimise further PK assessment of this antibody.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBreast NeoplasmsClinical Trials, Phase I as TopicFemaleGlycolipidsGlycoproteinsHumansLipid DropletsMiddle AgedModels, BiologicalPrognosisSampling StudiesSurvival RateAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedepitumomabGlycolipidsGlycoproteinsmilk fat globule

Identifiers

PMID20160731
PMCPMC2833251

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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.