Evidence map›Paper›PMID 36305957›Full record

Trial reportCancer chemotherapy and pharmacology2022

Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study.

Naoki Kotani, Justin J Wilkins, Janet R Wade, Steve Dang, Dhruvitkumar S Sutaria, Kenta Yoshida, Sameer Sundrani, Hao Ding, Josep Garcia, Heather Hinton and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03072238 (A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer), 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
0.9field-weighted citation impact, top 24% 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.

NCT03072238 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2017 to 2024Enrolled1,101ConditionsMetastatic Prostate CancerArmsIpatasertib, Abiraterone, Placebo, Prednisone/Prednisolone
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. 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 at 4 institutions in 3 countries.

Naoki KotaniGenentech, Inc., South San Francisco, CA, USA. kotani.naoki47@chugai-pharm.co.jp.ORCID 0000-0003-4817-1370
Justin J WilkinsOccams Coöperatie UA, Amstelveen, The Netherlands.
Janet R WadeOccams Coöperatie UA, Amstelveen, The Netherlands.
Steve DangGenentech, Inc., South San Francisco, CA, USA.
Dhruvitkumar S SutariaGenentech, Inc., South San Francisco, CA, USA.
Kenta YoshidaGenentech, Inc., South San Francisco, CA, USA.
Sameer SundraniGenentech, Inc., South San Francisco, CA, USA.
Hao DingGenentech, Inc., South San Francisco, CA, USA.
Josep GarciaF. Hoffmann-La Roche AG, Basel, Switzerland.
Heather HintonF. Hoffmann-La Roche AG, Basel, Switzerland.
Rucha Sane *Genentech, Inc., South San Francisco, CA, USA.
Pascal Chanu *Department of Clinical Pharmacology, Genentech/Roche, Lyon, France.
Roche (Switzerland) · CHChugai Pharma (United States) · USRoche (France) · FRStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe exposure-response relationships for efficacy and safety of ipatasertib, a selective AKT kinase inhibitor, were characterized using data collected from 1101 patients with metastatic castration-resistant prostate cancer in the IPATential150 study (NCT03072238).

methodsExternal validation of a previously developed population pharmacokinetic model was performed using the observed pharmacokinetic data from the IPATential150 study. Exposure metrics of ipatasertib for subjects who received ipatasertib 400 mg once-daily orally in this study were generated as model-predicted area under the concentration-time curve at steady state (AUC

resultsA statistically significant correlation between ipatasertib AUC

conclusionsThe exposure-efficacy results indicated that patients receiving ipatasertib may continue benefiting from this treatment at the administered dose, despite some variability in exposures, while the exposure-safety results suggested increased risks of AEs with ipatasertib treatment and/or increased ipatasertib exposures.

Indexed as

PiperazinesProstatic Neoplasms, Castration-ResistantPyrimidinesHumansMaleipatasertibPiperazinesPyrimidinesAKT inhibitorExposure–responseIpatasertibIPATential150Metastatic castration-resistant prostate cancer

Identifiers

PMID36305957
PMCPMC9637074
OpenAlexW4307496629

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.