Evidence map›Paper›PMID 23404627›Full record

Trial reportCancer chemotherapy and pharmacology2013

A multi-histology trial of fostamatinib in patients with advanced colorectal, non-small cell lung, head and neck, thyroid, and renal cell carcinomas, and pheochromocytomas.

Sook Ryun Park, Giovanna Speranza, Richard Piekarz, John J Wright, Robert J Kinders, Lihua Wang, Thomas Pfister, Jane B Trepel, Min-Jung Lee, Sylvia Alarcon and 4 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

20 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
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  15. Targeting Cancer Cells with BET Bromodomain Inhibitors.Cold Spring Harbor perspectives in medicine · 2017
    Review
  16. Article
  17. Ibrutinib: a paradigm shift in management of CLL.Expert review of hematology · 2014
    Review
  18. Article
  19. Implementation of validated pharmacodynamic assays in multiple laboratories: challenges, successes, and limitations.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
    Article
  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

14 authors at 3 institutions in 1 country.

Sook Ryun ParkDivision of Cancer Treatment and Diagnosis, National Cancer Institute, 31 Center Drive, 3A44, Bethesda, MD 20892, USA.
Giovanna Speranza
Richard Piekarz
John J Wright
Robert J Kinders
Lihua Wang
Thomas Pfister
Jane B Trepel
Min-Jung Lee
Sylvia Alarcon
Seth M Steinberg
Jerry Collins
James H Doroshow
Shivaani Kummar
National Cancer Institute · USCenter for Cancer Research · USFrederick National Laboratory for Cancer Research · US

Funding

Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Signal Transduction Events and the Regulation of Cell GrowthZICSC006743 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI TREPEL, JANE B · 2009 to 2023
$13.8M
Phase 01 Clinical TrialsZIABC011078 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI DOROSHOW, JAMES · 2009 to 2025
$9.0M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

purposeA multi-cohort phase II study of fostamatinib, an oral multi-kinase inhibitor, was conducted to determine the response rate in patients with advanced colorectal (CRC), thyroid, non-small cell lung, head and neck, and renal cell carcinomas, and pheochromocytomas.

methodsPatients received 200 mg fostamatinib BID in 4-week cycles with response assessed every 2 cycles. Blood was collected for pharmacokinetic analysis and measurements of circulating tumor cells and circulating endothelial (progenitor) cells (CE(P)Cs).

resultsA total of 37 patients (22 CRC), median of 4 prior therapies, were enrolled. Due to toxicities in four of the first five patients, the study was amended to incorporate a dose escalation phase for each histology. The maximum-tolerated dose was established at 50 mg BID in CRC but was not established for the other cancers. Common grade 3/4 toxicities included transaminitis, hyperbilirubinemia, and hypertension. Pharmacokinetic profile was similar to previous reports. Seventy-three percent of CRC patients had liver involvement and 91 % had prior anti-angiogenic therapy. Patients with abnormal liver tests at baseline were more likely to experience grade ≥ 2 hepatotoxicity than those with normal tests (44 vs. 0 %). No responses were observed; disease stabilization rate was 27 % in CRC. Reduction in CECs following treatment was associated with a better disease stabilization rate (75 vs. 0 %) in CRC.

conclusionFostamatinib had limited anti-tumor activity in this first clinical trial in patients with advanced refractory solid tumors; reduction in CECs and CEPs was indicative of anti-angiogenic effects. Abnormal liver testing at baseline appeared to influence drug tolerability.

Indexed as

Adrenal Gland NeoplasmsAdultAgedAged, 80 and overAminopyridinesCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellCohort StudiesColorectal NeoplasmsEndothelial CellsFemaleHead and Neck NeoplasmsHumansKidney NeoplasmsLung NeoplasmsMaleAminopyridinesfostamatinibMorpholinesOxazinesProtein Kinase InhibitorsPyridinesPyrimidines

Identifiers

PMID23404627
PMCPMC4457312
OpenAlexW2000853637

What OpenQuestion holds

Textmetadata
LicenceTDM
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.