Evidence map›Paper›PMID 37315114›Full record

Trial reportThe oncologist2023

Activity of Tivozanib in Non-clear Cell Renal Cell Carcinoma: Subgroup Analysis From a Phase II Randomized Discontinuation Trial.

Pedro C Barata, Alexander Chehrazi-Raffle, Kimberly D Allman, Aviva Asnis-Alibozek, Vijay Kasturi, Sumanta K Pal

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00502307 (A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 21% 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.

NCT00502307 phase2completednot on this map

A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib (AV-951) in Patients With Renal Cell Carcinoma

TypeinterventionalSponsorAVEO Pharmaceuticals, Inc.Ran2007 to 2010Enrolled272ConditionsCarcinoma, Renal CellArmsTivozanib (AV-951), Placebo comparator
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. 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

6 authors at 3 institutions in 1 country.

Pedro C BarataDepartment of Medicine, Case Comprehensive Cancer Center, Seidman Cancer Center, University Hospitals Case Medical Center, Cleveland, OH, USA.ORCID 0000-0002-8890-2951
Alexander Chehrazi-RaffleDepartment of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Kimberly D AllmanAVEO Oncology, an LG Chem Company, Boston, MA, USA.
Aviva Asnis-AlibozekAVEO Oncology, an LG Chem Company, Boston, MA, USA.
Vijay KasturiAVEO Oncology, an LG Chem Company, Boston, MA, USA.
Sumanta K PalDepartment of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
AVEO Oncology (United States) · USCity of Hope · USUniversity Hospitals Cleveland Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-clear cell renal cell carcinoma (nccRCC) is a blanket term for a collection of heterogeneous and biologically diverse RCC histologies, including but not limited to papillary, chromophobe, and unclassified subtypes. Tivozanib is a selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) that demonstrated activity in RCC with clear cell component. The objective of this analysis was to determine the efficacy of tivozanib in histologically unclassified/mixed RCC.

methodsWe identified patients with nccRCC enrolled in Study 201 (NCT00502307) between October 2007 and July 2008. This was a phase II randomized discontinuation trial of tivozanib in patients with RCC who had no prior VEGFR-targeted treatment. Clinical outcomes including investigator-assessed objective response rate (ORR), disease control rate (DCR, defined by complete response + partial response + stable disease), and progression-free survival (PFS) were examined.

resultsOf the 272 patients enrolled, 46 (16.9%) patients had nccRCC: 11 (4%) papillary, 2 (0.7%) chromophobe, 2 (0.7%) collecting duct, and 31 (11.4%) mixed/unclassified. Of the 46 patients with nccRCC, 38 were continuously treated with tivozanib and the best ORR was 21.1% (confirmed) and 31.6% (confirmed and unconfirmed). The DCR was 73.7% and median PFS was 6.7 months (95% confidence interval, 125-366 days). There were no new safety signals compared to the ITT population. Limitations include the small number of individual nccRCC subtypes and the randomized discontinuation design.

conclusionTivozanib demonstrated activity and a favorable safety profile in patients with nccRCC. These data add to the body of evidence supporting the use of VEGFR-TKI in advanced nccRCC.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAngiogenesis InhibitorsHumansPhenylurea CompoundsQuinolinesReceptor Protein-Tyrosine KinasesReceptors, Vascular Endothelial Growth FactorVascular Endothelial Growth Factor AAngiogenesis InhibitorsPhenylurea CompoundsQuinolinesReceptor Protein-Tyrosine KinasesReceptors, Vascular Endothelial Growth FactortivozanibVascular Endothelial Growth Factor Ametastatic renal cell carcinomanon-clear celltivozanibtyrosine kinase inhibitorVEGFR-TKI

Identifiers

PMID37315114
PMCPMC10546822
OpenAlexW4380730227

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.