Evidence map›Paper›PMID 15292716›Full record

Trial reportInvestigational new drugs2004

A phase I surrogate endpoint study of SU6668 in patients with solid tumors.

Henry Q Xiong, Roy Herbst, Silvana C Faria, Catherine Scholz, Darren Davis, Edward F Jackson, Timothy Madden, David McConkey, Marshall Hicks, Kenneth Hess and 2 more

Abstract readClinical TrialClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Pericytes Act as Key Players in Spinal Cord Injury.The American journal of pathology · 2019
    Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Multi-kinase inhibitors, AURKs and cancer.Medical oncology (Northwood, London, England) · 2016
    Review
  12. Review
  13. Article
  14. Review
  15. Use of kinase inhibitors to correct ΔF508-CFTR function.Molecular & cellular proteomics : MCP · 2012
    Article
  16. Article
  17. Article
  18. HCC and angiogenesis: possible targets and future directions.Nature reviews. Clinical oncology · 2011
    Review
  19. Article
  20. 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

12 authors at 1 institution in 1 country.

Henry Q XiongDepartment of Gastrointestinal Medical Oncology, University of Texas, M. D. Anderson Cancer Center, Houston, TX, USA.
Roy Herbst
Silvana C Faria
Catherine Scholz
Darren Davis
Edward F Jackson
Timothy Madden
David McConkey
Marshall Hicks
Kenneth Hess
Chusilp Arthur Charnsangavej
James L Abbruzzese
The University of Texas MD Anderson Cancer Center · US

Funding

Targeted Assessment of Antiangiogenic TherapyU54CA090810 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI ABBRUZZESE, JAMES L. · 2001 to 2006
$8.2M
Phase I Studies of Targeted Anti-Cancer TherapiesU01CA062461 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI YAO, JAMES C · 1994 to 2013
$7.2M
NCI NIH HHS U01-CA-62461-09NCI NIH HHS U54-CA-90810-02
6 · The paper itself

Abstract

purposeTo evaluate the biologic effects of SU6668 in patients with solid tumors using comprehensive measures of pharmacokinetics (PK), functional imaging, and tissue correlative studies. EXPERIMENTAL

designEligible patients with tumors accessible for core needle biopsy were treated with SU6668 at doses of 200 or 400 mg/m(2)/day. Functional computed tomography (CT) scan and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) were performed at baseline and repeated 4 weeks and 12 weeks after treatment for analysis of tumor angiogenesis. The PK was analyzed using a high-performance liquid chromatography assay. Tumor specimens obtained via core needle biopsy at baseline and 4 weeks later were analyzed for the biologic effects of SU6668.

resultsSix of a total of seven patients received treatment for at least 3 months and underwent comprehensive correlative studies, including PK, imaging, and tissue biopsy. Functional CT showed that five of six patients had decreased blood flow in tumors in response to treatment, and DCE-MRI results indicated significant change of area under the signal intensity vs. time curve (AUC) and/or maximum slope (maximum rate of signal intensity change) in two of four patients evaluated with this technique. PK studies showed that the mean apparent oral clearance (Cl(oral)) measured on day 1 was 6.3 +/- 2.7 L/hr/m(2), yielding a mean AUC of 16.6 +/- 4.3 mg/L.hr. By day 22, the Cl(oral) was 40% more than that observed on day 1.

conclusionIt is feasible to evaluate the biologic effects of antiangiogenic agents using comprehensive surrogate measures.

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsArea Under CurveBiomarkers, TumorDose-Response Relationship, DrugEndpoint DeterminationFemaleHumansIndolesMagnetic Resonance ImagingMaleMiddle AgedNeoplasmsOxindolesAngiogenesis InhibitorsBiomarkers, TumorIndolesorantinibOxindolesPropionatesPyrroles

Identifiers

PMID15292716
OpenAlexW2056410635

What OpenQuestion holds

Textmetadata
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.