Evidence map›Paper›PMID 30406838›Full record

ArticleCancer chemotherapy and pharmacology2019

Oral administration of irinotecan in patients with solid tumors: an open-label, phase I, dose escalating study evaluating safety, tolerability and pharmacokinetics.

I Kümler, P Grundtvig Sørensen, J Palshof, E Høgdall, W Skovrider-Ruminski, S Theile, A Fullerton, P G Nielsen, B Vittrup Jensen, D L Nielsen

Abstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
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  5. Article
  6. A High-Content Screen for C/EBPα Expression Identifies Novel Therapeutic Agents in Dedifferentiated Liposarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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  8. 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

10 authors.

I KümlerDepartment of Oncology, Herlev and Gentofte Hospital, Herlev, Denmark. ibekml01@regionh.dk.ORCID 0000-0001-5082-3660
P Grundtvig SørensenDepartment of Oncology, Herlev and Gentofte Hospital, Herlev, Denmark.
J PalshofDepartment of Oncology, Herlev and Gentofte Hospital, Herlev, Denmark.
E HøgdallDepartment of Pathology, Herlev and Gentofte Hospital, Herlev, Denmark.
W Skovrider-RuminskiDepartment of Pathology, Herlev and Gentofte Hospital, Herlev, Denmark.
S TheileDepartment of Oncology, Herlev and Gentofte Hospital, Herlev, Denmark.
A FullertonOncoral Pharma ApS, c/o Jusmedico, Kongevejen 371, Holte, Denmark.
P G NielsenOncoral Pharma ApS, c/o Jusmedico, Kongevejen 371, Holte, Denmark.
B Vittrup JensenDepartment of Oncology, Herlev and Gentofte Hospital, Herlev, Denmark.
D L NielsenDepartment of Oncology, Herlev and Gentofte Hospital, Herlev, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral drug formulations have several advantages compared to intravenous formulation. Apart from patient convenience and favorable pharmacoeconomics, they offer the possibility of frequent drug administration at home. In this study, we present a new oral irinotecan formulation designed as an enteric coated immediate release tablet which in pre-clinical studies has shown good exposure with low variability.

methodsA phase I, dose escalating study to assess safety, tolerability, pharmacokinetics and efficacy of an oral irinotecan formulation and to establish the maximum tolerated dose (MTD). Each treatment cycle was once-daily irinotecan for 14 days followed by 1 week rest.

results25 patients were included across four cohorts; 3 patients were included in cohort 1 (20 mg/m

conclusionsOral irinotecan was generally well tolerated; side effects were manageable and similar in type to those observed with intravenous irinotecan. Hematological toxicities were few and only grade 1/2. In this heavily pre-treated patient population, oral irinotecan demonstrated activity even among patients previously treated with irinotecan.

Indexed as

Administration, OralAgedAged, 80 and overCohort StudiesDrug Administration ScheduleFemaleFollow-Up StudiesGlucuronosyltransferaseHumansIrinotecanMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPrognosisTissue DistributionGlucuronosyltransferaseIrinotecanTopoisomerase I InhibitorsUGT1A1 EnzymeDose findingOral irinotecanPhase I

Identifiers

PMID30406838
PMCPMC6373187

What OpenQuestion holds

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Registered trials

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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.