Relapsed Ewing SarcomaPhase 2LINESNCT02546544
Eurosarc Trial of Linsitinib in Advanced Ewing Sarcoma
A Phase 2 study testing Linsitinib in people with Relapsed Ewing Sarcoma and Refractory Ewing Sarcoma, run by University of Oxford at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed Ewing Sarcoma, Refractory Ewing Sarcoma
- What is being tested?
- Linsitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Mar 2014to 15 Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmed original (no new biopsy required) diagnosis of Ewing sarcoma, preferably with EWSR in situ hybridisation break apart probe.
- First, second or any relapse or refractory disease to conventional treatment
- Current disease state for which there either is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- Has recovered from prior chemotherapy-related toxicity to ≤ grade 2
- Male or female, Age ≥ 18 and ≤70 years
- Life expectancy of at least 4 months
Show all 26Show fewer
- WHO performance score of 0-2
- Must be able to take oral medication
- Is willing and able to comply with the protocol for the duration of the study, and scheduled visits and examinations, including biopsies and PET-CT scans
- Written (signed and dated) informed consent
- Tumour at biopsy accessible site; in the case of lung metastases, accessible with VATS procedure
- Tumour progression documented with imaging in the 6 months prior to study entry
- At least one measurable lesion on CT scan performed in past 14 days of minimum size 1 cm and 18FDG uptake positive
- Cardiac Ejection Fraction (Echocardiogram) ≥45%
- Fasting glucose ≤ 150 mg/dL (8.3 mmol/L) with no history of diabetes. Concurrent use of non-insulinotropic anti-hyperglycaemic therapy for diabetes is permitted if the dose has been stable for ≥ 4 weeks at the time of enrolment
- 16. Haematological and biochemical indices within the specified ranges as below:
- Haemoglobin (Hb) ≥9 g/dL (Previous transfusion is allowed)
- Absolute neutrophil count (ANC) ≥1.0 x 109/L without growth factor support
- Platelet count > 80.x 109/L (Previous transfusion is allowed)
- Direct Bilirubin <1.5 times the upper limit of normal (ULN)
- Serum alanine aminotransferase (ALT) <2.5 x ULN for age and ≤ 5 x ULN if liver metastasis
- Aspartate aminotransferase (AST) <2.5 x ULN for age
- Alkaline phosphatase <2.5 x ULN for age
- CPK <2.5 x ULN for age
- Serum creatinine ≤1.5 x ULN for age
- Potassium, magnesium and calcium within normal limits (supplementation and re-testing is permitted)
Who cannot join
- Females: Pregnant or breast-feeding, or of childbearing potential unless effective methods of contraception are used. Males: Unless effective methods of contraception are used.
- Significant active cardiac disease including: History (within last 6 months) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea).
- History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded; uncontrolled high blood pressure (no greater than 2 SD above the mean for age for SBP and DBP), unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias
- Mean QTcF interval ≥ 450 msec based on analysis of screening visit and pre-dose ECGs.
- 5. Use of drugs that have a known risk of causing Torsades de Pointes (TdP) within 14 days prior to registration
- Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine within 7 days prior to registration. Linsitinib is primarily metabolized by CYP1A2 and inhibitors/inducers of CYP1A2 could alter the pharmacokinetics of linsitinib. Other less potent CYP1A2 inhibitors/inducers are not excluded
Show all 14Show fewer
- Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results
- Any other active malignancy, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions
- History of cerebrovascular accident (CVA) within 6 months prior to entry that resulted in ongoing neurologic instability
- Patients with symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable
- Major surgery within 4 weeks prior to study treatment
- Prior anti- IGF-1R treatment
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Germany1 site
Pediatric Hematology and Oncology, University Hospital Münster
Münster, 48149
Netherlands1 site
Department of Clinical Oncology, Leiden University Medical Center
Leiden, Postzone K1-P, P.O. Box 9600
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
About this study
Official title: Phase II Trial of Linsitinib (Anti-IGF-1R/IR) in Patients With Relapsed and/or Refractory Ewing Sarcoma
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.
Read the detailed description
An important development in ES has been the identification of IGF-1R pathway dependency. The reasons for the remarkable single agent efficacy observed in a small subset of patients remains unknown, as is the relative lack of efficacy in the majority of patients. There may be heterogeneity in response due to partial signal pathway inhibition at the tumour level, inherent resistance in ES cells or the presence of alternative pathway activation through IR-A receptor signalling.
Here we aim to establish pharmacodynamic responses in ES tumours using functional imaging 18FDG-PET-CT and repeat post treatment biopsy for biomarker responses, toxicity and clinical outcome to the dual anti-IGF-1R/IR kinase blocking single agent linsitinib.
This is a single arm phase 2 study utilising adaptive Bayesian analysis. Approximately 40 patients will be recruited the national bone sarcoma centre in 5 EU countries over 18 months.
Eligible patients will take 4x 150 mg tablets once a day, days 1-3 of the week followed by 4 days off - repeated for 3 weeks = one treatment cycle. Patients can remain on treatment for as long as they gain clinical benefit.
The primary objectives are to determine the effect of linsitinib on the patient's tumours in terms of changes in biomarker and PET scans and to establish the safety of the trial drug (linsitinib) in Ewing sarcoma at the dose and treatment schedule being used in the trial.
- Conditions
- Relapsed Ewing Sarcoma, Refractory Ewing Sarcoma
- Being tested
- Linsitinib
- Keywords
- Linsitinib, anti-IGF-1R/IR, Ewing Sarcoma, dual IGF-1R/IR inhibition, Relapsed Ewing Sarcoma, Refractory Ewing Sarcoma, Metastatic Ewing Sarcoma
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinsitinibDrug
Also called OSI-906, ASP7487
| Study group | Role | What they receive |
|---|---|---|
| Linsitinib | Other | Linsitinib is to be taken orally once a day on days 1-3, 8-10 and 15-17 on a 21 day cycle. The starting dose is 600 mg Receives: Drug: Linsitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Metabolic Response as Evaluated by PERCIST v1.0
Metabolic response measured by PERCIST v1.0 using SULpeak. This methodology used SULpeak to measure change in glucose uptake in the tumour.
Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels.
Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.
Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Partial Metabolic Response".
Stable Metabolic Disease - Not CMR, PMR or PMD. Progressive metabolic disease - Increase of more than 30% in 18F-FDG SUL peak. OR: Visible increase in extent of 18F-FDG tumour uptake (75% in TLG volume with no decline in SUL. OR: New 18F-FDG-avid lesions that are typical of cancer and not related to treatment effect or infection.
Measured: Pre- and Post- dose responses following 1 cycle (21 days) of treatment
Number of Participants With a Toxic Event
A patient is defined as having a toxic event if they experienced at least one grade 3 adverse event (CTCAE v4.0 grade)
Measured: Following 6 cycles of treatment (up to 6 months)
Secondary outcomes (4)
Clinical Outcome (PFS, DSS)
To determine the clinical outcome through assessment of
- Progression free survival; where length of survival is defined in whole days as the time from entry into the study until Ewing sarcoma progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Disease specific survival; where length of survival is defined in whole days as the time from entry into the study until death from Ewing sarcoma.
Measured: Duration of study (up to 18 months)
Pharmacokinetics Assays of Following Linsitinib Treatment (Plasma Concentrations of Linsitinib)
Plasma concentrations of linsitinib (ng/ml).
Samples were taken 3 hours post-dose at Cycle 1 days 1,15,17, Cycle 2 day 3, Cycle 3 days 1 and 3, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, and End of Treatment (this could occur at anytime during the 6 cycles).
Measured: Cycle 1 days 1,15,17, Cycle 2 day 3, Cycle 3 days 1 and 3, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1 and End of Treatment.0
Number of Participants With a Radiological Response as Evaluated by RECIST v1.1
Radiological response measured using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)
Per RECIST for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable disease (SD), Not CR, PR or PD.
Measured: Measured cycle 1 day 15, cycle 3 and cycle 6
Number of Participants With a Metabolic Response as Evaluated by EORTC 1.0
Metabolic response measured by PERCIST v1.0 using SULpeak. This methodology used SULpeak to measure change in glucose uptake in the tumour.
Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels.
Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.
Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Partial Metabolic Response".
Stable Metabolic Disease - Not CMR, PMR or PMD. Progressive metabolic disease - Increase of more than 30% in 18F-FDG SUL peak. OR: Visible increase in extent of 18F-FDG tumour uptake (75% in TLG volume with no decline in SUL. OR: New 18F-FDG-avid lesions that are typical of cancer and not related to treatment effect or infection.
Measured: Measured cycle 1 day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startMar 2014
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed Ewing SarcomaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC, European Commission, Astellas Pharma Inc, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Andrew B Hassan, BMBCh FRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546544
- Sponsor's protocol ID
- OCTO_038
- Other IDs
- 2012-000616-28
- Acronym
- LINES
- Status last verified
- Oct 2017
- First submitted
- 6 Aug 2014
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Linsitinib (Anti-IGF-1R/IR) in Patients With Relapsed and/or Refractory Ewing Sarcoma
- ClinicalTrials.gov ID
- NCT02546544
- Acronym / sponsor ID
- LINES / OCTO_038
- Conditions
- Relapsed Ewing Sarcoma, Refractory Ewing Sarcoma
- Keywords
- Linsitinib, anti-IGF-1R/IR, Ewing Sarcoma, dual IGF-1R/IR inhibition, Relapsed Ewing Sarcoma, Refractory Ewing Sarcoma, Metastatic Ewing Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC, European Commission, Astellas Pharma Inc, Oxford University Hospitals NHS Trust
- Study start
- Mar 2014
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An important development in ES has been the identification of IGF-1R pathway dependency. The reasons for the remarkable single agent efficacy observed in a small subset of patients remains unknown, as is the relative lack of efficacy in the majority of patients. There may be heterogeneity in response due to partial signal pathway inhibition at the tumour level, inherent resistance in ES cells or the presence of alternative pathway activation through IR-A receptor signalling.
Here we aim to establish pharmacodynamic responses in ES tumours using functional imaging 18FDG-PET-CT and repeat post treatment biopsy for biomarker responses, toxicity and clinical outcome to the dual anti-IGF-1R/IR kinase blocking single agent linsitinib.
This is a single arm phase 2 study utilising adaptive Bayesian analysis. Approximately 40 patients will be recruited the national bone sarcoma centre in 5 EU countries over 18 months.
Eligible patients will take 4x 150 mg tablets once a day, days 1-3 of the week followed by 4 days off - repeated for 3 weeks = one treatment cycle. Patients can remain on treatment for as long as they gain clinical benefit.
The primary objectives are to determine the effect of linsitinib on the patient's tumours in terms of changes in biomarker and PET scans and to establish the safety of the trial drug (linsitinib) in Ewing sarcoma at the dose and treatment schedule being used in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linsitinib | Other | Drug: LinsitinibLinsitinib is to be taken orally once a day on days 1-3, 8-10 and 15-17 on a 21 day cycle. The starting dose is 600 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histological or cytological confirmed original (no new biopsy required) diagnosis of Ewing sarcoma, preferably with EWSR in situ hybridisation break apart probe.
- First, second or any relapse or refractory disease to conventional treatment
- Current disease state for which there either is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- Has recovered from prior chemotherapy-related toxicity to ≤ grade 2
- Male or female, Age ≥ 18 and ≤70 years
Key exclusion criteria (14 listed)
- Females: Pregnant or breast-feeding, or of childbearing potential unless effective methods of contraception are used. Males: Unless effective methods of contraception are used.
- Significant active cardiac disease including: History (within last 6 months) of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac disease includes second/third degree heart block; clinically significant ischemic heart disease; superior vena cava (SVC) syndrome; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea).
- History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded; uncontrolled high blood pressure (no greater than 2 SD above the mean for age for SBP and DBP), unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias
- Mean QTcF interval ≥ 450 msec based on analysis of screening visit and pre-dose ECGs.
- 5. Use of drugs that have a known risk of causing Torsades de Pointes (TdP) within 14 days prior to registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinsitinibAlso: OSI-906, ASP7487 | Drug | Linsitinib |
Primary outcome
Number of Participants With a Metabolic Response as Evaluated by PERCIST v1.0
Time frame: Pre- and Post- dose responses following 1 cycle (21 days) of treatment
Metabolic response measured by PERCIST v1.0 using SULpeak. This methodology used SULpeak to measure change in glucose uptake in the tumour. Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels. Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions. Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Partial Metabolic Response". Stable Metabolic Disease - Not CMR, PMR or PMD. Progressive metabolic disease - Increase of more than 30% in 18F-FDG SUL peak. OR: Visible increase in extent of 18F-FDG tumour uptake (75% in TLG volume with no decline in SUL. OR: New 18F-FDG-avid lesions that are typical of cancer and not related to treatment effect or infection.
Number of Participants With a Toxic Event
Time frame: Following 6 cycles of treatment (up to 6 months)
A patient is defined as having a toxic event if they experienced at least one grade 3 adverse event (CTCAE v4.0 grade)
4 secondary outcomes
Clinical Outcome (PFS, DSS)
Time frame: Duration of study (up to 18 months)
Pharmacokinetics Assays of Following Linsitinib Treatment (Plasma Concentrations of Linsitinib)
Time frame: Cycle 1 days 1,15,17, Cycle 2 day 3, Cycle 3 days 1 and 3, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1 and End of Treatment.0
Number of Participants With a Radiological Response as Evaluated by RECIST v1.1
Time frame: Measured cycle 1 day 15, cycle 3 and cycle 6
Number of Participants With a Metabolic Response as Evaluated by EORTC 1.0
Time frame: Measured cycle 1 day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Information about the trial on the Oncology Clinical Trials Office (OCTO) website. OCTO run the trial on behalf of the sponsor, the University of OxfordLink provided by the sponsor.
- ISRCTN registryLink provided by the sponsor.
Related trials for Relapsed Ewing Sarcoma
RecruitingPhase 1
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas
Relapsed Sarcomas
Active, not recruitingPhase 1
C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)
Relapsed Neuroblastoma, Refractory Neuroblastoma
RecruitingPhase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Refractory and/or Relapsed Metastatic Solid Tumors
Not yet recruitingPhase 2
Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors
Relapsed or Refractory Pediatric Malignant Solid Tumors (Including Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma)
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew B Hassan, BMBCh FRCP principal investigator
University of Oxford
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Linsitinib in people with Relapsed Ewing Sarcoma and Refractory Ewing Sarcoma, run by University of Oxford at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Italy, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Metabolic Response as Evaluated by PERCIST v1.0 (time frame: Pre- and Post- dose responses following 1 cycle (21 days) of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019; AzTrials last refreshed its copy on 26 Oct 2026.