Evidence map›Paper›PMID 22955257›Full record

Trial reportCancer chemotherapy and pharmacology2012

Population pharmacokinetics of farletuzumab, a humanized monoclonal antibody against folate receptor alpha, in epithelial ovarian cancer.

Colm Farrell, Charles Schweizer, Jason Wustner, Susan Weil, Masayuki Namiki, Tomohisa Nakano, Kenya Nakai, Martin D Phillips

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

9 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Targeted therapy in ovarian cancer.Women's health (London, England) · 2016
    Review
  7. Review
  8. Review
  9. Targeting signaling pathways in epithelial ovarian cancer.International journal of molecular sciences · 2013
    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

8 authors at 3 institutions in 2 countries.

Colm FarrellICON Clinical Research, Ellicott, MD, USA.
Charles Schweizer
Jason Wustner
Susan Weil
Masayuki Namiki
Tomohisa Nakano
Kenya Nakai
Martin D Phillips
Morphotek (United States) · USEisai (Japan) · JPPinnacle Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this analysis was to develop a population pharmacokinetic model for farletuzumab, a humanized immunoglobulin (Ig)G(1) monoclonal antibody (mAb) to the folate receptor alpha, which is a receptor over-expressed in ovarian cancer, but largely absent from normal tissue.

methodsIn total, 2,472 samples were included in the building of the pharmacokinetic model. Farletuzumab 12.5-400 mg/m(2) had been administered via intravenous infusion to 79 patients with advanced ovarian cancer enrolled in one of the two clinical studies. Data were analyzed by a nonlinear mixed-effects modeling approach.

resultsFarletuzumab pharmacokinetics was best described by a two-compartment model with first-order (linear) elimination. In the final model, estimated values of clearance and volume of distribution of the central compartment were 0.00784 l/h and 3.00 l, respectively. Body weight was the only covariate investigated that explained inter-patient variability in clearance and the central volume of distribution. There was no effect of age, human anti-human antibodies, or concomitant chemotherapy on the pharmacokinetics of farletuzumab. Simulations showed that, when the mg/kg/week dose was maintained, steady-state exposure to farletuzumab was similar with dosing every week or every 3 weeks.

conclusionsThe pharmacokinetic parameters of farletuzumab are similar to those of other IgG mAbs. The results support weight-based dosing of farletuzumab on a weekly or 3-weekly schedule.

Indexed as

Models, BiologicalAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBody WeightCarcinoma, Ovarian EpithelialComputer SimulationDose-Response Relationship, DrugDrug InteractionsFemaleFolate Receptor 1HumansInfusions, IntravenousMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsfarletuzumabFolate Receptor 1

Identifiers

PMID22955257
PMCPMC3485533
OpenAlexW2046218565

What OpenQuestion holds

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LicenceCC BY
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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.