Evidence map›Paper›PMID 22918720›Full record

Trial reportInvestigational new drugs2013

Phase II trial of single-agent foretinib (GSK1363089) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Tanguy Seiwert, John Sarantopoulos, Howard Kallender, Stewart McCallum, Harold N Keer, George Blumenschein

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
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 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 5% 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

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  7. Review
  8. Article
  9. The MET Oncogene: An Update on Targeting Strategies.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  10. MERTK Inhibition as a Targeted Novel Cancer Therapy.International journal of molecular sciences · 2024
    Review
  11. Article
  12. Review
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  16. Review
  17. Therapeutic Targeting of the Gas6/Axl Signaling Pathway in Cancer.International journal of molecular sciences · 2021
    Review
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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 5 institutions in 2 countries.

Tanguy SeiwertThe University of Chicago, 5841 S Maryland Ave, MC2115, Chicago, IL 60637, USA. tseiwert@medicine.bsd.uchicago.edu
John Sarantopoulos
Howard Kallender
Stewart McCallum
Harold N Keer
George Blumenschein
GlaxoSmithKline (Netherlands) · NLExelixis (United States) · USThe University of Texas Health Science Center at San Antonio · USThe University of Texas MD Anderson Cancer Center · USUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundForetinib is a small-molecule, oral multikinase inhibitor primarily targeting the mesenchymal epithelial transition (MET) factor receptor, and the vascular endothelial growth factor receptor 2. We conducted a phase II study to evaluate the single-agent activity and tolerability of foretinib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).

methodsAn open-label, single-arm, multicenter trial employing a Simon 2-stage design was conducted with a total of 41 patients planned for the study. One or more responses in the first 14 patients were required in order to progress to the second stage. Foretinib was administered as 240 mg orally for 5 consecutive days of a 14-day treatment cycle (5/9 schedule) to patients with recurrent and/or metastatic SCCHN.

resultsFourteen patients were enrolled. The study did not meet criteria for continuing to the second stage. A maximum of 30 cycles were administered (median = 4.0). Fifty percent of patients (7/14) showed stable disease (SD), 43% of patients (6/14) experienced tumor shrinkage and two patients had prolonged disease stabilization for ≥13 months. The most common adverse events were fatigue, constipation and hypertension, which were manageable with additional medication or adjustments to the dosing schedule.

conclusionForetinib 240 mg on a 5/9 schedule was generally well tolerated. SD was the best-observed outcome, with minor tumor shrinkage detected in nearly half of all patients. The efficacy results, prolonged disease stabilization and tolerable side-effect profile, support further investigation, possibly in combination with other targeted agents or cytotoxic chemotherapy for SCCHN.

Indexed as

AgedAged, 80 and overAnilidesBone NeoplasmsCarcinoma, Squamous CellDose-Response Relationship, DrugFemaleFollow-Up StudiesHead and Neck NeoplasmsHumansLiver NeoplasmsLung NeoplasmsLymphatic MetastasisMaleMaximum Tolerated DoseMiddle AgedAnilidesGSK 1363089QuinolinesVascular Endothelial Growth Factor Receptor-2

Identifiers

PMID22918720
PMCPMC3589657
OpenAlexW1964550379

What OpenQuestion holds

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LicenceCC BY
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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.