A study to look at the effectiveness of chemotherapy plus bevacizumab compared with chemotherapy alone in children and adolescents with metastatic soft tissue sarcoma (STS) (BERNIE)
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
- United Kingdom
NCT00643565 2007-005017-19 BO20924
Clinical Trial Results
Once the last participant has completed the clinical trial, Roche will analyze the combined results of the trial and create a report summarizing the results. The analysis of the data takes time; however Roche aims to make the summary of the outcome of the clinical trial available within 12 months after the last clinical trial participant has completed the trial. Roche may also provide a summary of trial outcome prior to the end of the clinical trial. Below you can find the available results of the BERNIE clinical trial.
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.
An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma
- childhood and adolescent patients aged >/=6 months to 18 years of age
- metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
- adequate bone marrow function
- adequate renal and liver function
- adequate blood clotting
- previous malignant tumors
- tumor invading major blood vessels
- prior systemic anti-tumor treatment
For the latest version of this information please go to www.forpatients.roche.com