Evidence map›Paper›PMID 37505272›Full record

Trial reportCancer chemotherapy and pharmacology2023

An IQ consortium analysis of starting dose selection for oncology small molecule first-in-patient trials suggests an alternative NOAEL-based method can be safe while reducing time to the recommended phase 2 dose.

Bart A Jessen, Paul Cornwell, Sean Redmond, Thomas Visalli, Marie Lemper, Todd Bunch, Timothy Hart

Erratum issuedAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Bart A Jessen *Pfizer, Drug Safety Research and Development, San Diego, CA, 92121, USA. bart.jessen@pfizer.com.ORCID 0000-0002-9691-6931
Paul CornwellEli Lilly, Nonclinical Safety Assessment, Indianapolis, IN, USA.
Sean RedmondClinical Pharmacology & Safety Sciences, AstraZeneca Pharmaceuticals, Waltham, MA, 02451, USA.
Thomas VisalliEisai Inc., Global Nonclinical Regulatory, Nutley, NJ, 07110, USA.
Marie LemperDevelopment Science, UCB, Inc., Cambridge, MA, 02140, USA.
Todd BunchNonclinical Safety Evaluation, Bristol Myers Squibb, Princeton, NJ, 08540, USA.
Timothy Hart *GlaxoSmithKline, IVIVT, Collegeville, PA, 19426, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The first-in-patient (FIP) starting dose for oncology agents should be reasonably safe and provide potential therapeutic benefit to the patient. For late-stage oncology patients, this dose is often based on the ICH S9 guidance, which was developed primarily based on experience with cytotoxic chemotherapeutic agents using the rodent STD

Indexed as

Antineoplastic AgentsNeoplasmsDose-Response Relationship, DrugHumansMaximum Tolerated DoseMedical OncologyNo-Observed-Adverse-Effect LevelAntineoplastic AgentsFirst-in-patientNOAEL-basedRecommended starting dose

Identifiers

PMID37505272
PMCPMC10638197

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.