Evidence map›Paper›PMID 22291006›Full record

ArticleNeuro-oncology2012

A phase I study of LY317615 (enzastaurin) and temozolomide in patients with gliomas (EORTC trial 26054).

Roy Rampling, Marc Sanson, Thiery Gorlia, Denis Lacombe, Christina Lai, Myriam Gharib, Walter Taal, Clemens Stoffregen, Rodney Decker, Martin J van den Bent

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Neuro-oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00516607 (Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.4field-weighted citation impact, top 11% 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.

NCT00516607 phase1unknown statusnot on this map

Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas

TypeinterventionalSponsorEuropean Organisation for Research and Treatment of Cancer - EORTCRan2007Enrolled28ConditionsBrain and Central Nervous System TumorsArmsenzastaurin hydrochloride, temozolomide, pharmacological study
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
  2. Review
  3. AKT/GSK3β Signaling in Glioblastoma.Neurochemical research · 2017
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Targeted therapy in gliomas.Current oncology reports · 2014
    Review
  9. Article
  10. Review
  11. Review
  12. 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

10 authors at 5 institutions in 6 countries.

Roy RamplingGlasgow University/Beatson West of Scotland Cancer Centre, Glasgow, UK. roy.rampling@glasgow.ac.uk
Marc Sanson
Thiery Gorlia
Denis Lacombe
Christina Lai
Myriam Gharib
Walter Taal
Clemens Stoffregen
Rodney Decker
Martin J van den Bent
European Organisation for Research and Treatment of Cancer · BEEli Lilly (Germany) · DEEli Lilly (United States) · USSorbonne Université · FRAssistance Publique – Hôpitaux de Paris · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We report a phase 1 study to examine the safety and recommended dose of the oral protein kinase C-beta inhibitor (anti-angiogenic) enzastaurin in combination with single-agent temozolomide. The study was conducted in patients with recurrent glioblastoma or newly diagnosed disease that was not treatable with standard (chemo)radiotherapy. Patients were treated with standard dose temozolomide (200 mg/m(2) for 5 days every 4 weeks) together with daily oral enzastaurin. Three dose levels of enzastaurin were investigated: 250 mg daily (OD), 500 mg OD, and 250 mg twice daily (BID). Dose-limiting toxicity was determined in the first 2 cycles, but treatment continued until limiting toxicity or disease progression was identified. Twenty-eight patients were enrolled. No dose-limiting toxicity was noted at 250 mg OD or 500 mg OD. However, at 250 mg BID, 2 dose-limiting episodes of thrombocytopenia were noted. The recommended dose for enzastaurin in combination with standard 4-weekly temozolomide is therefore 500 mg OD. The pharmacokinetics of enzastaurin in combination with temozolomide was evaluated. Temozolomide did not appear to effect enzastaurin exposures at the 250 mg or 500 mg OD dose levels.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsDacarbazineFemaleGlioblastomaHumansIndolesMaleMaximum Tolerated DoseMiddle AgedTemozolomideYoung AdultDacarbazineenzastaurinIndolesTemozolomide

Identifiers

PMID22291006
PMCPMC3280806
OpenAlexW2105295086

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.