Evidence map›Paper›PMID 30083962›Full record

Trial reportInvestigational new drugs2018

Phase II randomized, double-blind, placebo-controlled study of tivantinib in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).

Paul Monk, Glenn Liu, Walter M Stadler, Susan Geyer, Ying Huang, John Wright, Miguel Villalona-Calero, James Wade, Russell Szmulewitz, Shilpa Gupta and 6 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 26% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Dysregulated microRNAs in prostate cancer:Iranian journal of basic medical sciences · 2024
    Article
  8. Review
  9. Tivantinib Hampers the Proliferation of Glioblastoma Cells via PI3K/Akt/Mammalian Target of Rapamycin (mTOR) Signaling.Medical science monitor : international medical journal of experimental and clinical research · 2019
    Article
  10. Review
  11. Article
  12. Article
  13. 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

16 authors at 13 institutions in 1 country.

Paul MonkOhio State University, A433b Starling-Loving Hall, 310 W. 10th ave, Columbus, OH, 43082, USA. Paul.monk@osumc.edu.ORCID http://orcid.org/0000-0002-0508-2987
Glenn LiuUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Ave, Madison, WI, 53705, USA.
Walter M StadlerUniversity of Chicago, 5841 S Maryland Ave, Chicago, IL, 60637, USA.
Susan GeyerUniversity of South Florida, 4202 E Fowler Ave, Tampa, FL, 33620, USA.
Ying HuangOhio State University, 320 W 10th Ave, Columbus, OH, 43210-1280, USA.
John WrightNational Cancer Institute, 9609 Medical Center Dr., MSC, Bethesda, MD, 9739, USA.
Miguel Villalona-CaleroMiami Cancer Institute, 8900 N Kendall Dr, Miami, FL, 33176-2118, USA.
James WadeCancer Care Specialists of Central Illinois, 210 W Mckinley Ave, Decatur, IL, 62526, USA.
Russell SzmulewitzUniversity of Chicago Medical Center, 5841 S Maryland Ave # MC2115, Chicago, IL, 60637-1447, USA.
Shilpa GuptaUniversity of Minnesota, 420 Delaware St SE, Minneapolis, MN, 55455-0341, USA.
Amir MortazaviOhio State University, 320 W 10th Ave, Columbus, OH, 43210-1280, USA.
Robert DreicerUniversity of Virginia School of Medicine, PO Box 800716, Charlottesville, VA, 22908-0716, USA.
Roberto PiliIndiana University, 535 Barnhill Drive, Indianapolis, IN, 46202, USA.
Nancy DawsonGeorgetown-Lombardi Comprehensive Cancer Center, 3800 Reservoir Rd NW, Washington, DC, 20007-2113, USA.
Saby GeorgeRoswell Park Cancer Institute, 6 Symphony Cir, Orchard Park, NY, 14127, USA.
Jorge A GarciaTaussig Cancer Institute, 9500 Euclid Ave, Cleveland, OH, 44195-0001, USA.
The Ohio State University · USCancer Care Specialists of Illinois · USGeorgetown University Medical Center · USIndiana University – Purdue University Indianapolis · USMiami Heart Research Institute · USNational Cancer Institute · USRoswell Park Comprehensive Cancer Center · USUniversity of Chicago · USUniversity of Chicago Medical Center · USUniversity of Minnesota · USUniversity of South Florida · USUniversity of Virginia · USUniversity of Wisconsin Carbone Cancer Center · US

Funding

UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
NCI NIH HHS HHSN261201100070CNCI NIH HHS UM1 CA186712
6 · The paper itself

Abstract

Background Tivantinib is a non-ATP competitive inhibitor of c-MET receptor tyrosine kinase that may have additional cytotoxic mechanisms including tubulin inhibition. Prostate cancer demonstrates higher c-MET expression as the disease progresses to more advanced stages and to a castration resistant state. Methods 80 patients (pts) with asymptomatic or minimally symptomatic mCRPC were assigned (2:1) to either tivantinib 360 mg PO BID or placebo (P). The primary endpoint was progression free survival (PFS). Results Of the 80 pts. enrolled, 78 (52 tivantinib, 26 P) received treatment and were evaluable. Median follow up is 8.9 months (range: 2.3 to 19.6 months). Patients treated with tivantinib had significantly better PFS vs. those treated with placebo (medians: 5.5 mo vs 3.7 mo, respectively; HR = 0.55, 95% CI: 0.33 to 0.90; p = 0.02). Grade 3 febrile neutropenia was seen in 1 patient on tivantinib while grade 3 and 4 neutropenia was recorded in 1 patient each on tivantinib and placebo. Grade 3 sinus bradycardia was recorded in two men on the tivantinib arm. Conclusions Tivantinib has mild toxicity and improved PFS in men with asymptomatic or minimally symptomatic mCRPC.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBradycardiaDisease-Free SurvivalDouble-Blind MethodHumansMaleMiddle AgedNeutropeniaProstatic Neoplasms, Castration-ResistantProtein Kinase InhibitorsProto-Oncogene Proteins c-metPyrrolidinonesQuinolinesAntineoplastic AgentsARQ 197Protein Kinase InhibitorsProto-Oncogene Proteins c-metPyrrolidinonesQuinolinesCancerCastration resistantProstateTivantinib

Identifiers

PMID30083962
PMCPMC6153554
OpenAlexW2885735821

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.