Evidence map›Paper›PMID 27990167›Full record

ArticleDrugs in context2016

Relative bioavailability of three formulations of galunisertib administered as monotherapy in patients with advanced or metastatic cancer.

Ivelina Gueorguieva, Ann Cleverly, Durisala Desaiah, Analia Azaro, Joan Seoane, Irene Braña, Elisabet Sicart, Colin Miles, Michael M Lahn, Malcolm I Mitchell and 1 more

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PubMed Full text at PMC Publisher
In one paragraph

Article in Drugs in context, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Ivelina GueorguievaEli Lilly and Company, Erl Wood, UK.
Ann CleverlyEli Lilly and Company, Erl Wood, UK.
Durisala DesaiahEli Lilly and Company, Indianapolis, IN, USA.
Analia AzaroMedical Oncology, Vall d'Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain.
Joan SeoaneVall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain.
Irene BrañaMedical Oncology, Vall d'Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain.
Elisabet SicartMedical Oncology, Vall d'Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain.
Colin MilesEli Lilly and Company, Erl Wood, UK.
Michael M LahnEli Lilly and Company, Indianapolis, IN, USA.
Malcolm I MitchellEli Lilly and Company, Indianapolis, IN, USA.
Jordi RodonMedical Oncology, Vall d'Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveGalunisertib (LY2157299 monohydrate), an inhibitor of the transforming growth factor β (TGFβ) pathway, is currently under investigation in several clinical trials involving multiple tumor types. The primary objective of this study was to assess relative bioavailability of two new galunisertib formulations developed using the roller compaction (RC) dry-milled (RCD) and RC slurry-milled (RCS) processes, compared with the existing formulation developed using the high-sheer wet granulation (HSWG) process. The secondary objective was to report the safety profile after a single dose of the three formulations.

methodsPatients with advanced or metastatic cancer were enrolled into this single-center, 3-period, 6-sequence crossover study. Patients were assigned sequentially to 1 of 6 sequences in blocks of 6 to ensure that all 6 sequences have the same number of completers. A patient entering a sequence received a different galunisertib formulation as a single 150 mg dose orally during each of the 3 periods. Each period was separated from the next by a washout interval of at least 48 hours. Pharmacokinetic (PK) parameters, including area under curve (AUC) and C

resultsOf the 14 patients who entered and completed the study, 13 patients were included in the final statistical analysis. AUC(0-t

conclusionsIn this relative bioavailability study comparing galunisertib formulations after a single dose, RCD and RCS formulations had similar exposure and safety profile compared with the HSWG formulation.

Indexed as

adverse drug eventarea under curvebiological availabilityhalf-lifeLY2157299neoplasmspharmacokineticstransforming growth factor beta

Identifiers

PMID27990167
PMCPMC5147053

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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.