Evidence map›Paper›PMID 39096851›Full record

ArticleEuropean journal of cancer (Oxford, England : 1990)2024

Phase 1 study of NEDD8 activating enzyme inhibitor pevonedistat in combination with chemotherapy in pediatric patients with recurrent or refractory solid tumors (ADVL1615).

Jennifer H Foster, Joel M Reid, Charles Minard, Sarah Woodfield, Kristina Z Denic, Emasenyie Isikwei, Stephan D Voss, Marvin Nelson, Xiaowei Liu, Stacey L Berg and 2 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in European journal of cancer (Oxford, England : 1990), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
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  11. 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

12 authors.

Jennifer H FosterTexas Children's Hospital, Baylor College of Medicine, Dan L Duncan Comprehensive Cancer Center, Houston, TX, USA. Electronic address: jhfoster@bcm.edu.
Joel M ReidMayo Clinic, Rochester, MN, USA.
Charles MinardInstitute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX, USA.
Sarah WoodfieldTexas Children's Hospital, Baylor College of Medicine, Dan L Duncan Comprehensive Cancer Center, Houston, TX, USA.
Kristina Z DenicMayo Clinic, Rochester, MN, USA.
Emasenyie IsikweiMayo Clinic, Rochester, MN, USA.
Stephan D VossDepartment of Radiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Marvin NelsonChildren's Hospital Los Angeles, Radiology, Keck USC School of Medicine, Los Angeles, CA, USA.
Xiaowei LiuChildren's Oncology Group, Monrovia, CA, USA.
Stacey L BergTexas Children's Hospital, Baylor College of Medicine, Dan L Duncan Comprehensive Cancer Center, Houston, TX, USA.
Elizabeth FoxDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.
Brenda J WeigelDepartment of Pediatrics, University of Minnesota, Minneapolis, MN, USA.

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Lila J. Rutten · 1985 to 2026
$151.3M
PEP-CTN EHR to RAVE supplementUM1CA228823 · NCI · PUBLIC HEALTH INSTITUTE · PI Elizabeth Fox · 2018 to 2026
$39.6M
TRAINING GRANT IN CLINICAL PHARMACOLOGYT32GM008685 · NIGMS · MAYO CLINIC ROCHESTER · PI Liewei Wang · 1998 to 2026
$8.2M
NCI Research Specialist (Clinician Scientist) AwardR50CA275928 · NCI · BAYLOR COLLEGE OF MEDICINE · PI Jennifer Haunani Foster · 2023 to 2026
$549k
NCI NIH HHS P30 CA015083NCI NIH HHS R50 CA275928NCI NIH HHS UM1 CA228823NIGMS NIH HHS T32 GM008685
6 · The paper itself

Abstract

purposeThe objective of this study was to determine the recommended Phase 2 dose (RP2D) of pevonedistat, a first in class inhibitor of NEDD8 activating enzyme, in combination with irinotecan (IRN) and temozolomide (TMZ) in children with cancer.

methodsThis Phase 1 study used a rolling 6 design to evaluate escalating doses of pevonedistat in combination with standard doses of IRN and TMZ in pediatric patients with recurrent/refractory solid or CNS tumors. During cycle 1, pevonedistat was administered intravenously on days 1, 8, 10, and 12, with IRN (IV, 50 mg/m

resultsThirty patients enrolled; all were eligible and evaluable for toxicity. Six patients each enrolled on pevonedistat dose levels (DL) 1 (15 mg/m

conclusionsPevonedistat in combination with IRN/TMZ is well tolerated in children with solid or CNS tumors. The RP2D of pevonedistat is 35 mg/m

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCyclopentanesNeoplasmsPyrimidinesAdolescentChildChild, PreschoolDrug Resistance, NeoplasmFemaleHumansIrinotecanMaleMaximum Tolerated DoseNEDD8 ProteinNeoplasm Recurrence, LocalTemozolomideCyclopentanesIrinotecanNEDD8 ProteinNEDD8 protein, humanpevonedistatPyrimidinesTemozolomideCNS tumorsDrug developmentPediatric oncologyPhase 1Sarcoma

Identifiers

PMID39096851
PMCPMC11392690

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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.