Evidence map›Paper›PMID 23417696›Full record

Trial reportInvestigational new drugs2013

A phase 2 multicenter study of tivantinib (ARQ 197) monotherapy in patients with relapsed or refractory germ cell tumors.

Darren R Feldman, Lawrence H Einhorn, David I Quinn, Yohann Loriot, Johnathan K Joffe, David J Vaughn, Aude Fléchon, Julio Hajdenberg, Abdel-Baset Halim, Hamim Zahir and 1 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
5.5field-weighted citation impact, top 4% 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

21 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Development of a novelEuropean journal of nuclear medicine and molecular imaging · 2024
    Article
  4. Article
  5. Review
  6. Review
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  8. Immune checkpoint inhibitors in genitourinary malignancies.Current oncology (Toronto, Ont.) · 2020
    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. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. c-Met as a Target for Personalized Therapy.Translational oncogenomics · 2015
    Review
  19. Review
  20. 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

11 authors at 10 institutions in 4 countries.

Darren R FeldmanMemorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA. feldmand@mskcc.org
Lawrence H Einhorn
David I Quinn
Yohann Loriot
Johnathan K Joffe
David J Vaughn
Aude Fléchon
Julio Hajdenberg
Abdel-Baset Halim
Hamim Zahir
Robert J Motzer
Memorial Sloan Kettering Cancer Center · USCentre Léon Bérard · FRDaiichi Sankyo (Germany) · DEDaiichi Sankyo (United States) · USIndiana University – Purdue University Indianapolis · USOrlando Health · USSt James's University Hospital · GBUniversité Paris Cité · FRUniversity of Pennsylvania · USUniversity of Southern California · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
6 · The paper itself

Abstract

backgroundTivantinib is a selective, small-molecule inhibitor of the MET receptor tyrosine kinase. Preclinical and phase 1 data suggested a possible role for MET in the pathophysiology of germ cell tumors (GCTs) and a potential clinical benefit from tivantinib in patients with these tumors.

methodsMen (≥ 16 years) with relapsed or refractory, histologically confirmed, non-central nervous system GCTs received oral tivantinib 360 mg twice daily in 28-day cycles until progressive disease or unacceptable toxicity. The primary endpoint was objective response rate in the first 4 cycles, with study termination for <2 responses among the first 21 patients. Secondary endpoints included 12-week progression-free survival (PFS), overall survival (OS), and safety.

resultsTwenty-seven patients were enrolled in 9 months (median age, 32 years). Most patients had tumors with nonseminoma histology (n = 25), and primary tumor sites were testis (n = 24) and mediastinum (n = 3). Among 25 evaluable patients, no objective responses were observed; accrual was halted when the 21st patient became evaluable. Best response was stable disease (n = 5). Median PFS was 1 month, the 12-week PFS rate was 21 %, and median OS was 6 months. Grade 3 or 4 adverse events considered related to study drug included grade 3 pneumonia and grade 3 syncope (n = 1, each).

conclusionsTivantinib was well tolerated but did not demonstrate single-agent activity in patients with relapsed/refractory GCTs. Rapid accrual to this phase 2 trial was achieved in this rare patient population through multicenter collaboration.

Indexed as

AdolescentAdultAntineoplastic AgentsDemographyDisease-Free SurvivalHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasms, Germ Cell and EmbryonalProto-Oncogene Proteins c-metPyrrolidinonesQuinolinesRecurrenceTreatment OutcomeYoung AdultAntineoplastic AgentsARQ 197Proto-Oncogene Proteins c-metPyrrolidinonesQuinolines

Identifiers

PMID23417696
OpenAlexW2023031195

What OpenQuestion holds

Textmetadata
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.