Evidence map›Paper›PMID 15870716›Full record

Trial reportBritish journal of cancer2005

Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumours.

A Awada, A Hendlisz, T Gil, S Bartholomeus, M Mano, D de Valeriola, D Strumberg, E Brendel, C G Haase, B Schwartz and 1 more

Open access · hybridAbstract readClinical TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 3 pooled it
14.1field-weighted citation impact, top 1% 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

114 citing papers in PubMed, 3 syntheses or guidelines pooled it, 338 citations in OpenAlex.

  1. Pooled it
  2. Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
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  12. Two drug interaction studies of sirolimus in combination with sorafenib or sunitinib in patients with advanced malignancies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2011
    Trial
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  15. Phase I trial of a combination of the multikinase inhibitor sorafenib and the farnesyltransferase inhibitor tipifarnib in advanced malignancies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2009
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54 more citing papers are in PubMed but not listed here.

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

11 authors at 4 institutions in 3 countries.

A AwadaJules Bordet Institute, Brussels, Belgium. ahmad.awada@bordet.be
A Hendlisz
T Gil
S Bartholomeus
M Mano
D de Valeriola
D Strumberg
E Brendel
C G Haase
B Schwartz
M Piccart
Institut Jules Bordet · BEBayer (Germany) · DEBayer (United States) · USWest German Heart and Vascular Center Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BAY 43-9006 is a novel dual-action Raf kinase and vascular endothelial growth factor receptor (VEGFR) inhibitor that targets tumour cell proliferation and tumour angiogenesis. This Phase I study was undertaken to determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), pharmacokinetics, and tumour response profile of oral BAY 43-9006 in patients with advanced, refractory solid tumours. BAY 43-9006 was administered daily for repeated cycles of 21 days on/7 days off. A total of 44 patients were enrolled at doses from 50 to 800 mg b.i.d. Pharmacokinetic profiles of BAY 43-9006 in plasma were determined during the first treatment cycle. The most frequently reported adverse events over multiple cycles were gastrointestinal (75%), dermatologic (71%), constitutional (68%), pain (64%), or hepatic (61%) related. A MTD of 400 mg b.i.d. BAY 43-9006 was defined. BAY 43-9006 was absorbed rapidly; steady-state conditions were reached within 7 days. BAY 43-9006 exposure increased nonproportionally with increasing dose. In all, 32 patients were evaluated for tumour response: 15 patients showed tumour progression, 16 patients experienced stable disease (>6 months in eight patients), and one patient with renal cell carcinoma achieved a partial response. BAY 43-9006 given for 21 days with 7 days off treatment was safe, well tolerated, and showed antitumour activity.

Indexed as

AdultAgedBenzenesulfonatesCarcinoma, Renal CellDrug Administration ScheduleFemaleHumansKidney NeoplasmsMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNiacinamidePhenylurea CompoundsPyridinesSorafenibBenzenesulfonatesNiacinamidePhenylurea CompoundsPyridinesSorafenib

Identifiers

PMID15870716
PMCPMC2361774
OpenAlexW2018348203

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.