Evidence map›Paper›PMID 21297127›Full record

Trial reportNeuro-oncology2011

A phase II study evaluating the efficacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma.

Patrick Y Wen, David Schiff, Timothy F Cloughesy, Jeffrey J Raizer, John Laterra, Melanie Smitt, Michael Wolf, Kelly S Oliner, Abraham Anderson, Min Zhu and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Neuro-oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00427440 (A Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Malignant Glioma), which is not on this map. Cited by 89 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT00427440 phase2completednot on this map

A Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Malignant Glioma

TypeinterventionalSponsorAmgenRan2006 to 2013Enrolled61ConditionsAdvanced Malignant GliomaArmsAMG 102 at 20 mg/kg, AMG 102 at 10 mg/kg
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Incorporation of biomarkers in phase II studies of recurrent glioblastoma.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
    Pooled it
  4. Guideline
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Review
  13. The MET Oncogene: An Update on Targeting Strategies.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  14. Current approaches in glioblastoma multiforme immunotherapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Review
  15. Development of a novelEuropean journal of nuclear medicine and molecular imaging · 2024
    Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review

29 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

12 authors.

Patrick Y WenCenter for Neuro-Oncology, Dana Farber/Brigham and Women's Cancer Center, Shields Warren 430 D, Boston, MA 02115, USA. patrick_wen@dfci.harvard.edu
David Schiff
Timothy F Cloughesy
Jeffrey J Raizer
John Laterra
Melanie Smitt
Michael Wolf
Kelly S Oliner
Abraham Anderson
Min Zhu
Elwyn Loh
David A Reardon

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase II study evaluated the efficacy and safety of AMG 102 (rilotumumab), a fully human monoclonal antibody against hepatocyte growth factor/scatter factor (HGF/SF), in patients with recurrent glioblastoma (GBM). Patients with histologically confirmed, measurable recurrent GBM or gliosarcoma (World Health Organization grade 4) and ≤3 relapses or prior systemic therapies received AMG 102 (10 or 20 mg/kg) by infusion every 2 weeks. The primary endpoint was best confirmed objective response rate (central assessment) per Macdonald criteria. Of the 61 patients who enrolled, 60 received AMG 102. Twenty-nine patients (48%) had previously received bevacizumab. There were no objective responses per central assessment, but 1 patient had an objective response per investigator assessment. Median overall survival (95% CI) in the 10- and 20-mg/kg cohorts was 6.5 months (4.1-9.8) and 5.4 months (3.4-11.4), respectively, and progression-free survival (PFS) per central assessment was 4.1 weeks (4.0-4.1) and 4.3 weeks (4.1-8.1), respectively. PFS was similar among patients who had previously received bevacizumab compared with bevacizumab-naive patients. The most common adverse events were fatigue (38%), headache (33%), and peripheral edema (23%). AMG 102 serum concentrations increased approximately dose-proportionally with 2-fold accumulation at steady state. Plasma total HGF/SF and soluble c-Met concentrations increased 12.05- and 1.12-fold, respectively, from baseline during AMG 102 treatment. AMG 102 monotherapy at doses up to 20 mg/kg was not associated with significant antitumor activity in heavily pretreated patients with recurrent GBM.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiomarkers, TumorBrain NeoplasmsFemaleGlioblastomaHepatocyte Growth FactorHumansMaleMiddle AgedNeoplasm Recurrence, LocalProto-Oncogene Proteins c-metSurvival RateTissue DistributionAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBiomarkers, TumorHepatocyte Growth FactorProto-Oncogene Proteins c-metrilotumumab

Identifiers

PMID21297127
PMCPMC3064694

What OpenQuestion holds

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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.