Evidence map›Paper›PMID 29177975›Full record

Trial reportInvestigational new drugs2018

Hepatic safety analysis of trabectedin: results of a pharmacokinetic study with trabectedin in patients with hepatic impairment and experience from a phase 3 clinical trial.

Emiliano Calvo, Analia Azaro, Jordi Rodon, Luc Dirix, Manon Huizing, Francis Mark Senecal, Patricia LoRusso, Lorrin Yee, Italo Poggesi, Jan de Jong and 6 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
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. It is linked to 2 registered trials, which are 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
0.6field-weighted citation impact, top 27% 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.

NCT01273493 phase1completednot on this map

An Open-Label, Multicenter, Pharmacokinetic Study of Trabectedin in Subjects With Advanced Malignancies and Hepatic Dysfunction

TypeinterventionalSponsorJanssen Research & Development, LLCRan2010 to 2014Enrolled15ConditionsNeoplasm Metastases, Hepatic InsufficiencyArmsTrabectedin, Dexamethasone
NCT01343277 phase3completednot on this map

A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2011 to 2016Enrolled579ConditionsAdvanced Liposarcoma or LeiomyosarcomaArmsTrabectedin, Dacarbazine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. The Role of Trabectedin in Soft Tissue Sarcoma.Frontiers in pharmacology · 2022
    Review
  4. 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

16 authors at 10 institutions in 4 countries.

Emiliano CalvoSTART Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain. emiliano.calvo@start.stoh.com.
Analia AzaroMolecular Therapeutics Research Unit, Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
Jordi RodonMolecular Therapeutics Research Unit, Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
Luc DirixOncology Center GZA Hospitals Sint Augustinus, Translational Cancer Research Unit, Department of Medical Oncology, Antwerp, Belgium.
Manon HuizingAntwerp University Hospital, Antwerp, Belgium.
Francis Mark SenecalHem Onc Northwest PC, Tacoma, WA, USA.
Patricia LoRussoKarmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
Lorrin YeeNorthwest Medical Specialties PLLC, Tacoma, WA, USA.
Italo PoggesiJanssen-Cilag SpA, Cologno Monzese, Milan, Italy.
Jan de JongJanssen Research & Development, San Diego, CA, USA.
Spyros TriantosJanssen Research & Development, Raritan, NJ, USA.
Youn C ParkJanssen Research & Development, Raritan, NJ, USA.
Roland E KnoblauchJanssen Research & Development, Raritan, NJ, USA.
Trilok V ParekhJanssen Research & Development, Raritan, NJ, USA.
George D DemetriSarcoma Center and Ludwig Center, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
Margaret von MehrenFox Chase Cancer Center, Philadelphia, PA, USA.
Janssen (United States) · USAntwerp University Hospital · BEDana-Farber Cancer Institute · USFox Chase Cancer Center · USGZA Ziekenhuizen Campus Sint-Augustinus · BEJanssen (Italy) · ITNorthwest Medical Specialties · USThe Barbara Ann Karmanos Cancer Institute · USUniversitat Autònoma de Barcelona · ESVall d'Hebron Hospital Universitari · ES

Funding

WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Margaret von Mehren · 1985 to 2026
$138.8M
NCI NIH HHS P30 CA006927
6 · The paper itself

Abstract

Purpose Trabectedin is metabolized by the liver and has been associated with transient, noncumulative transaminase elevation. Two recent studies further characterize hepatic tolerability with trabectedin therapy: a phase 1 pharmacokinetic study (Study #1004; NCT01273493) in patients with advanced malignancies and hepatic impairment (HI), and a phase 3 study (Study #3007; NCT01343277) of trabectedin vs. dacarbazine in patients with advanced sarcomas and normal hepatic function. Methods In Study #1004, patients received a single 3-h intravenous (IV) infusion of trabectedin: control group, trabectedin 1.3 mg/m

Indexed as

AdultAgedFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLiverMaleMiddle AgedTrabectedinTrabectedinBilirubinHepatic impairmentOvarian cancerSoft tissue sarcomasTrabectedinTransaminases

Identifiers

PMID29177975
OpenAlexW2770518644

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.