Evidence map›Paper›PMID 32447421›Full record

ArticleCancer chemotherapy and pharmacology2020

A phase I dose-escalation study of the polyamine analog PG-11047 in patients with advanced solid tumors.

Tracy Murray Stewart, Apurva A Desai, Michael L Fitzgerald, Laurence J Marton, Robert A Casero

Open access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.6field-weighted citation impact, top 35% 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

13 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Polyamine metabolism and anti-tumor immunity.Frontiers in immunology · 2025
    Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. The Association between Spermidine/Spermine NInternational journal of molecular sciences · 2022
    Review
  13. 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

5 authors at 4 institutions in 1 country.

Tracy Murray StewartSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, 1650 Orleans Street, CRB 1, Room 562, Baltimore, MD, 21287, USA. tmurray2@jhmi.edu.ORCID http://orcid.org/0000-0001-8679-6414
Apurva A DesaiIllinois Cancer Specialists, Elgin, IL, 60123, USA.
Michael L Fitzgerald, Apex, NC, 27502, USA.
Laurence J MartonCancer Commons, Los Altos, CA, 94022, USA.
Robert A CaseroSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, 1650 Orleans Street, CRB 1, Room 551, Baltimore, MD, 21287, USA. rcasero@jhmi.edu.
Johns Hopkins University · USApex School of Theology · USCancer Care Specialists of Illinois · USCreative Commons · US

Funding

Spermine N1-Acetylase Induction in Lung CancersR01CA051085 · NCI · JOHNS HOPKINS UNIVERSITY · PI CASERO, ROBERT A. · 1990 to 2013
$4.7M
Identification of novel spermine oxidase (SMOX) inhibitors as probes for an emerging chemoprevention targetR01CA204345 · NCI · JOHNS HOPKINS UNIVERSITY · PI CASERO, ROBERT A., WOSTER, PATRICK M · 2016 to 2020
$3.4M
Self-immolative prodrug/miRNA nanoparticle combinations for cancer treatmentR01CA235863 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI CASERO, ROBERT A., OUPICKY, DAVID · 2019 to 2023
$2.3M
NCI NIH HHS R01 CA051085NCI NIH HHS R01 CA204345NCI NIH HHS R01 CA235863
6 · The paper itself

Abstract

purposePolyamines are essential for the sustained proliferation and biomass required by tumor cells. Bis-alkylated polyamine analogs are nonfunctional competitors of natural polyamines. Of these, PG-11047, a second-generation unsaturated analog of the polyamine spermine, has demonstrated anticancer activity in cell lines and animal models of multiple cancer types. This report describes the first phase I clinical trial to investigate PG-11047 in patients with advanced refractory metastatic solid tumors.

methodsForty-six patients were treated with 60-min intravenous infusions of PG-11047 using a 28-day dosing cycle with treatments on days 1, 8, and 15. Doses ranged from 50 to 750 mg. The treatment period consisted of at least two cycles.

resultsThe maximum tolerated dose of PG-11047 administered at this dosing schedule was 610 mg. Dose-limiting toxicities (DLT) were mainly gastrointestinal, including oral/anal mucositis and diarrhea; other DLTs included one case each of angioedema and a grade 3 alanine aminotransferase (ALT) increase. The most common adverse effects were fatigue and anorexia. Stable disease was documented in 30% of patients.

conclusionResults of this phase I trial suggest that PG-11047 can be safely administered to patients on the once weekly dosing schedule described. The manageable toxicity profile and high MTD determination provide a safety profile for further clinical studies, including those in combination with current chemotherapeutic agents.

Indexed as

AdultAgedAged, 80 and overDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasmsPrognosisSpermineTissue Distribution(N(1),N(12))bis(ethyl)-6,7-dehydrospermineSpermineBis-alkyl polyamine analogCancerChemotherapyClinical trial

Identifiers

PMID32447421
PMCPMC7337042
OpenAlexW3028111764

What OpenQuestion holds

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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.