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Eurosarc Trial of Linsitinib in Advanced Ewing Sarcoma

NCT02546544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-06-03

Study results available
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Summary

This is an international, multi-centre, single arm Bayesian designed phase 2 study to identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7 European centres. Each patient will be treated with single agent linsitinib, 600 mg orally once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue toxicity.

Conditions

  • Relapsed Ewing Sarcoma
  • Refractory Ewing Sarcoma

Interventions

DRUG

Linsitinib

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • European Commission

    collaborator OTHER

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew B Hassan, BMBCh FRCP · University of Oxford

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-07-15
Completion
2016-07-15

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02546544 on ClinicalTrials.gov