Evidence map›Paper›PMID 31343094›Full record

ArticleClinical and translational science2020

First-in-Human, Healthy Volunteers Integrated Protocol of ETC-206, an Oral Mnk 1/2 Kinase Inhibitor Oncology Drug.

Vincenzo Teneggi, Veronica Novotny-Diermayr, Lay Hoon Lee, Maryam Yasin, Pauline Yeo, Kantharaj Ethirajulu, Sylvia Bong Hwa Gan, Stephanie E Blanchard, Ranjani Nellore, Dhananjay N Umrani and 6 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.5field-weighted citation impact, top 41% 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

9 citing papers in PubMed, 16 citations in OpenAlex.

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  9. IL-6 induced upregulation of T-type CaJournal of neurophysiology · 2020
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 1 country.

Vincenzo TeneggiD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Veronica Novotny-DiermayrD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Lay Hoon LeeD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Maryam YasinD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Pauline YeoD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Kantharaj EthirajuluD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Sylvia Bong Hwa GanD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Stephanie E BlanchardD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Ranjani NelloreD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Dhananjay N UmraniD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Roberto GomeniPharmacometrica, La Fouillade, France.
Darren Lim Wan TeckSingHealth Investigational Medicine Unit, Singapore Health Services, Singapore, Singapore.
Greg LiSingHealth Investigational Medicine Unit, Singapore Health Services, Singapore, Singapore.
Qing Shu LuSingapore Clinical Research Institute, Singapore, Singapore.
Yang CaoSingapore Clinical Research Institute, Singapore, Singapore.
Alex MatterD3 (Drug Discovery and Development), A*STAR, Singapore, Singapore.
Agency for Science, Technology and Research · SGExperimental Drug Development Centre · SGSingapore Clinical Research Institute · SGSingHealth · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the last decade, drug development has tackled substantial challenges to improve efficiency and facilitate access to innovative medicines. Integrated clinical protocols and the investigation of targeted oncology drugs in healthy volunteers (HVs) have emerged as modalities with an increase in scope and complexity of early clinical studies and first-in-human (FIH) studies in particular. However, limited work has been done to explore the impact of these two modalities, alone or in combination, on the scientific value and on the implementation of such articulated studies. We conducted an FIH study in HVs with an oncology targeted drug, an Mnk 1/2 small molecule inhibitor. In this article, we describe results, advantages, and limitations of an integrated clinical protocol with an oncology drug. We further discuss and indicate points to consider when designing and conducting similar scientifically and operationally demanding FIH studies.

Indexed as

Clinical ProtocolsResearch DesignAdministration, OralAdultAntineoplastic AgentsCardiovascular DiseasesElectrocardiographyHealthy VolunteersHematologic NeoplasmsHumansIntracellular Signaling Peptides and ProteinsMaleMedical OncologyMiddle AgedMonitoring, AmbulatoryProtein Kinase InhibitorsAntineoplastic AgentsIntracellular Signaling Peptides and ProteinsMKNK1 protein, humanMKNK2 protein, humanProtein Kinase InhibitorsProtein Serine-Threonine Kinases

Identifiers

PMID31343094
PMCPMC6951458
OpenAlexW2963490365

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.