Cabozantinib in children, adolescents and young adults with osteosarcoma (CabOSTar)

 

Trial name Cabozantinib in osteosarcoma
Agents Cabozantinib
Phase II
Status Recruiting
Sponsor Ipsen

 

This is a randomized, open-label Phase II study to assess the efficacy and safety of maintenance therapy with cabozantinib plus best supportive care (BSC) vs. BSC in children, adolescents and young adults (AYA) with unresectable residual osteosarcoma.

Further information can be found on clinicaltrials.gov.

 

WHO is the trial for?
  • Children, adolescents and young adults (AYA) with unresectable residual osteosarcoma between ≥5 and ≤30 years of age
  • Patients with unresectable residual disease after standard chemotherapy treatment at diagnosis or first relapse, who have a partial response or stable disease at the end of conventional chemotherapy

WHAT is the key question that this trial is attempting to answer?

 The study evaluates the efficacy, tolerability and quality of life of patients receiving cabozantinib + best supportive care (BSC) vs. BSC in young patients with inoperable residual osteosarcoma.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcoma and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 The study is open for recruitment.

WHERE is the trial available?

 The trial is currently active in the US, Austria, Belgium, Canada, Denmark, France, Italy, the Netherlands, Poland, Spain and Sweden. More countries and study sites will open in the future.

Please check for current information here.

STUDY DESIGN: What does the study look like?

 There are 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Patients in one group will be assigned to cabozantinib + BSC, the other group will receive BSC.

BSC includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. but does not include tumor specific therapy.

HOW do I get more information?

 Patient organizations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken