Evidence map›Paper›PMID 23449360›Full record

ArticleBritish journal of cancer2013

A first-in-class, first-in-human, phase I trial of p28, a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in patients with advanced solid tumours.

M A Warso, J M Richards, D Mehta, K Christov, C Schaeffer, L Rae Bressler, T Yamada, D Majumdar, S A Kennedy, C W Beattie and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in British journal of cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00914914 (A Phase I Trial of p28), which is not on this map. Cited by 94 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 2 pooled it
12.1field-weighted citation impact, top 1% 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.

NCT00914914 phase1completednot on this map

A Phase I Trial of p28 (Cell Penetrating Peptide) in the Treatment of Refractory Solid Tumors

TypeinterventionalSponsorDr. Tapas K. Das GuptaRan2009 to 2011Enrolled15ConditionsRefractory Solid TumorsArmsp28
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 2 syntheses or guidelines pooled it, 179 citations in OpenAlex.

  1. Targeting p53 pathways: mechanisms, structures, and advances in therapy.Signal transduction and targeted therapy · 2023
    Pooled it
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  11. Pandora's Box of AML: HowBiomedicines · 2025
    Review
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  14. Intracellular redistribution of cell-penetrating peptide p28: A mechanism for enhanced anti-cancer activity.Journal of controlled release : official journal of the Controlled Release Society · 2025
    Article
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34 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

M A WarsoUIC Department of Surgery, Division of Surgical Oncology, Chicago, IL 60612, USA.
J M Richards
D Mehta
K Christov
C Schaeffer
L Rae Bressler
T Yamada
D Majumdar
S A Kennedy
C W Beattie
T K Das Gupta
University of Illinois Chicago · USIndo-American Center · USOncology Specialists · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis first-in-human, phase I clinical trial of p28 (NSC745104), a 28-amino-acid fragment of the cupredoxin azurin, investigated the safety, tolerability, pharmacokinetics and preliminary activity of p28 in patients with p53(+) metastatic solid tumours.

methodsA total of 15 patients were administered p28 i.v. as a short infusion three times per week for 4 weeks followed by a 2-week rest under an accelerated titration 3+3 dose escalation design until either a grade 3-related adverse event occurred or the maximum tolerated dose (MTD) was reached. Single-dose and steady-state serum pharmacokinetics were characterised. Assessments included toxicity, best objective response by RECIST 1.1 Criteria, and overall survival.

resultsNo patients exhibited any dose-limiting toxicities (DLTs), significant adverse events or exhibited an immune response (IgG) to the peptide. The No Observed Adverse Effect Level (NOAEL) and MTD were not reached. Seven patients demonstrated stable disease for 7-61 weeks, three a partial response for 44-125 weeks, and one a complete response for 139 weeks. Three patients are still alive at 158, 140, and 110 weeks post therapy completion.

conclusionp28 was tolerated with no significant adverse events. An MTD was not reached. Evidence of anti-tumour activity indicates a highly favourable therapeutic index and demonstrates proof of concept for this new class of non-HDM2-mediated peptide inhibitors of p53 ubiquitination.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsAzurinDrug Administration ScheduleFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisNo-Observed-Adverse-Effect LevelPeptide FragmentsTumor Suppressor Protein p53UbiquitinationAntineoplastic AgentsAzurinazurin (50-77)Peptide FragmentsTumor Suppressor Protein p53

Identifiers

PMID23449360
PMCPMC3619084
OpenAlexW2120313279

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Registered trials

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.