Evidence map›Paper›PMID 31835495›Full record

ArticleCancers2019

Phase 1 Dose Escalation Study of the Allosteric AKT Inhibitor BAY 1125976 in Advanced Solid Cancer-Lack of Association between Activating AKT Mutation and AKT Inhibition-Derived Efficacy.

Andreas Schneeweiss, Dagmar Hess, Markus Joerger, Andrea Varga, Stacy Moulder, Apostolia M Tsimberidou, Cynthia Ma, Sara A Hurvitz, Christine Rentzsch, Marion Rudolph and 5 more

Registry-linked trialAbstract read
In one paragraph

Article in Cancers, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01915576 (A Phase I, Multi-center, Non-randomized, Open-label, Dose Escalation Design Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1125976 in Subjects With Advanced Solid Tumors), which is not on this 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.

NCT01915576 phase1completednot on this map

A Phase I, Multi-center, Non-randomized, Open-label, Dose Escalation Design Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY 1125976 in Subjects With Advanced Solid Tumors

TypeinterventionalSponsorBayerRan2013 to 2016Enrolled79ConditionsNeoplasmsArmsBAY1125976
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Targeting Akt in cancer for precision therapy.Journal of hematology & oncology · 2021
    Review
  10. Article
  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

15 authors.

Andreas SchneeweissNational Center for Tumor Diseases, University Hospital Heidelberg and German Cancer Research Center, 69120 Heidelberg, Germany.
Dagmar HessKantonsspital St. Gallen, 9001 St. Gallen, Switzerland.
Markus JoergerKantonsspital St. Gallen, 9001 St. Gallen, Switzerland.ORCID 0000-0001-6602-6287
Andrea VargaInstitut Gustave Roussy, 94800 Villejuif, France.ORCID 0000-0002-8564-5451
Stacy MoulderMD Anderson Cancer Center, Houston, TX 77030, USA.
Apostolia M TsimberidouMD Anderson Cancer Center, Houston, TX 77030, USA.
Cynthia MaDepartment of Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA.
Sara A HurvitzDavid Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095, USA.
Christine RentzschBayer AG, 13353 Berlin, Germany.
Marion RudolphBayer AG, 13353 Berlin, Germany.
Silke ThieleBayer AG, 13353 Berlin, Germany.
Oliver BoixBayer AG, 13353 Berlin, Germany.ORCID 0000-0003-3704-0877
Gary WilkinsonBayer AG, 13353 Berlin, Germany.ORCID 0000-0003-1949-6205
Eleni LagkadinouBayer AG, 13353 Berlin, Germany.
Matthias OckerBayer AG, 13353 Berlin, Germany.ORCID 0000-0001-8263-6288

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Samuel Wheeler French · 1985 to 2026
$134.5M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167NCI NIH HHS P30 CA016042
6 · The paper itself

Abstract

This open-label, phase I first-in-human study (NCT01915576) of BAY 1125976, a highly specific and potent allosteric inhibitor of AKT1/2, aimed to evaluate the safety, pharmacokinetics, and maximum tolerated dose of BAY 1125976 in patients with advanced solid tumors. Oral dose escalation was investigated with a continuous once daily (QD) treatment (21 days/cycle) and a twice daily (BID) schedule. A dose expansion in 28 patients with hormone receptor-positive metastatic breast cancer, including nine patients harboring the

Indexed as

AKT inhibitorbiomarkerbreast cancerpharmacokineticsphase 1

Identifiers

PMID31835495
PMCPMC6966663

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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.