Evidence map›Paper›PMID 32037403›Full record

Trial reportBritish journal of cancer2020

A multicentre phase 1b/2 study of tivozanib in patients with advanced inoperable hepatocellular carcinoma.

Christos Fountzilas, Medhavi Gupta, Sunyoung Lee, Smitha Krishnamurthi, Bassam Estfan, Katy Wang, Kristopher Attwood, John Wilton, Robert Bies, Wiam Bshara and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01835223 (Multicenter Phase 1b/2 Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT01835223 phase1 / phase2completednot on this map

Multicenter Phase 1b/2 Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma

TypeinterventionalSponsorRoswell Park Cancer InstituteRan2013 to 2019Enrolled33ConditionsAdvanced Adult Hepatocellular Carcinoma, Non-Resectable Hepatocellular CarcinomaArmsTivozanib (1mg), Tivozanib (1.5mg)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Christos Fountzilas *Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Christos.Fountzilas@RoswellPark.org.ORCID http://orcid.org/0000-0003-3837-5644
Medhavi Gupta *Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Sunyoung LeeMD Anderson Cancer Center, Houston, TX, USA.
Smitha KrishnamurthiCleveland Clinic, Cleveland, OH, USA.
Bassam EstfanCleveland Clinic, Cleveland, OH, USA.
Katy WangRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Kristopher AttwoodRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
John WiltonRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Robert BiesUniversity at Buffalo, Buffalo, NY, USA.
Wiam BsharaRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Renuka IyerRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Roswell Park Comprehensive Cancer Center · USCleveland Clinic · USThe University of Texas MD Anderson Cancer Center · USUniversity at Buffalo, State University of New York · US

Funding

Two-Spirit Films in Indigenous Cancer HealthP30CA016056 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI MARK G FRATTINI · 1985 to 2026
$116.6M
Dako Omnis Autostainer for Screening Tumor Tissues with ImmunohistochemistryS10OD019977 · OD · ROSWELL PARK CANCER INSTITUTE CORP · PI OMILIAN, ANGELA · 2015 to 2015
$175k
NCI NIH HHS P30 CA016056NIH HHS S10 OD019977
6 · The paper itself

Abstract

backgroundHepatocellular carcinoma (HCC) is a major cause of cancer-related death. It is a highly vascular tumour with multiple angiogenic factors, most importantly vascular endothelial growth factor (VEGF), involved in HCC progression. Tivozanib is an oral inhibitor of VEGFR-1/2/3 with promising activity against HCC in vivo.

methodsWe conducted a phase 1b/2 study of tivozanib in patients with advanced HCC. The safety, dosing, pharmacokinetics, pharmacodynamics, and preliminary antineoplastic efficacy of tivozanib were evaluated.

resultsTwenty-seven patients received at least one dose of tivozanib. Using a 3+3 design, the recommended phase 2 dose (RP2D) of tivozanib was determined to be 1 mg per os once daily, 21 days on-7 days off. The median progression-free and overall survival were 24 weeks and 9 months, respectively, for patients treated at RP2D. The overall response rate was 21%. Treatment was well tolerated. A significant decrease in soluble plasma VEGFR-2 was noted, assuring adequate target engagement.

conclusionsAlthough this study did not proceed to stage 2, there was an early efficacy signal with a very favourable toxicity profile. A phase 1/2 trial of tivozanib in combination with durvalumab is currently underway.

trial registrationClinicalTrials.gov NCT01835223, registered on 15 April 2013.

Indexed as

AdultAgedAged, 80 and overCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedPhenylurea CompoundsQuinolinesReceptors, Vascular Endothelial Growth FactorSurvival AnalysisYoung AdultPhenylurea CompoundsQuinolinesReceptors, Vascular Endothelial Growth Factortivozanib

Identifiers

PMID32037403
PMCPMC7109127
OpenAlexW3004844875

What OpenQuestion holds

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LicenceCC BY
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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.