Evidence map›Paper›PMID 35219065›Full record

Trial reportJournal of pharmaceutical and biomedical analysis2022

Quantitation of the next-generation imipridone ONC206 in human plasma by a simple and sensitive UPLC-MS/MS assay for clinical pharmacokinetic application.

Jennifer C Goodell, Sara M Zimmerman, Cody J Peer, Varun Prabhu, Tyler Yin, William J Richardson, Arya Azinfar, John A Dunn, Mark Mullin, Brett J Theeler and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Journal of pharmaceutical and biomedical analysis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04541082 (A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 43% 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.

NCT04541082 phase1recruitingnot on this map

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

TypeinterventionalSponsorJazz PharmaceuticalsRan2020 to 2026Enrolled102ConditionsCentral Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Adult, Anaplastic OligodendrogliomaArmsONC206
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. ONC206 as a low-potency dopamine DNeuro-oncology advances
    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

12 authors at 3 institutions in 1 country.

Jennifer C GoodellClinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, USA.
Sara M ZimmermanClinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, USA.
Cody J PeerClinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, USA.
Varun PrabhuChimerix, Inc, Durham, NC, USA.
Tyler YinClinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, USA.
William J RichardsonClinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, USA.
Arya AzinfarClinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, USA.
John A DunnChimerix, Inc, Durham, NC, USA.
Mark MullinChimerix, Inc, Durham, NC, USA.
Brett J TheelerDepartment of Neurology, Uniformed Services University of the Health Sciences, USA.
Mark GilbertNeuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, USA.
William D FiggClinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD, USA. Electronic address: figgw@mail.nih.gov.
National Cancer Institute · USChimerix (United States) · USUniformed Services University of the Health Sciences · US

Funding

Pre-clinical Translational Research FacilityZICBC011641 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WU, JING · 2015 to 2025
$22.2M
Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZICSC006537 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$14.4M
Pharmacokinetic and Pharmacodynamic Modeling of Anticancer AgentsZ01BC010548 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2003 to 2008
$815k
Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZ01SC006537 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 1997 to 2008
$379k
Intramural NIH HHS Z01 BC010548Intramural NIH HHS Z01 SC006537Intramural NIH HHS ZIC SC006537
6 · The paper itself

Abstract

ONC206 is an imipridone derivative that is being developed clinically as a single agent given orally in a first-in-human trial (NCT04541082). This ongoing clinical trial requires pharmacokinetic analysis of ONC206 to fully characterize its pharmacologic profile. There is currently no published bioanalytical method for ONC206 quantitation. To understand the clinical pharmacokinetics of ONC206, a sensitive yet simple uHPLC-MS/MS method for quantitation of ONC206 in human plasma was developed. Protein-precipitation allowed rapid and sensitive bioanalytical measurement of ONC206 in human plasma. A Phenomenex Kinetex C18 (50 ×2.1 mm, 1.3 µm, 100 Å) analytical column achieved symmetrical and sharp chromatography peaks of ONC206 and the internal standard, [

Indexed as

Antineoplastic AgentsTandem Mass SpectrometryChromatography, High Pressure LiquidChromatography, LiquidHumansReproducibility of ResultsAntineoplastic AgentsClinical pharmacologyMass spectrometryONC206Ultra-HPLC

Identifiers

PMID35219065
PMCPMC8983588
OpenAlexW4212877388

What OpenQuestion holds

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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.