CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Linsitinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02546544
NCT02546544Phase 2Completed
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Phase II Trial of Linsitinib (Anti-IGF-1R/IR) in Patients With Relapsed and/or Refractory Ewing Sarcoma

University of Oxford·interventional·Posted Sep 11, 2015·Updated Jun 3, 2019

In Brief

A Phase 2 clinical trial evaluating Linsitinib for Relapsed Ewing Sarcoma and Refractory Ewing Sarcoma. Completed, enrolled 16 participants across 5 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed Ewing Sarcoma, Refractory Ewing Sarcoma
CountriesFrance, Germany, Italy, Netherlands, United Kingdom
CollaboratorsEuropean Organisation for Research and Treatment of Cancer - EORTC, European Commission, Astellas Pharma Inc, Oxford University Hospitals NHS Trust

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 11, 2015
Enrollment StartMar 1, 2014
Primary CompletionJul 15, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.8 years ago

Interventions

Linsitinibdrug