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ASSG Endorsed Clinical Study

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Title A Phase II Study of Panobinostat in Paediatric, Adolescent and Young Adult Patients with Solid Tumours Including Osteosarcoma, Malignant Rhabdoid Tumour/Atypical Teratoid Rhabdoid Tumours and Neuroblastoma.
Objective To evaluate the anti-tumour activity of continuous, low dose of panobinostat in patients with refractory solid tumours stratified by primary histology into osteosarcoma, malignant rhabdoid tumour/atypical teratoid rabdoid tumour (MRT/ATRT). and neuroblastoma
Type This is an open label, Phase II, multicentre study.
Population Patients must be < 40 years of age and must have been histologically diagnosed with osteosarcoma, neuroblastoma or MRT/ATRT at time of diagnosis or relapse.
Treatment Panobinostat will then be administered as a continuous daily oral dose (minimum 10mg/m2 - maximum 16mg/m2), for up to a year. Dosing will follow a dose escalation scheme for each stratum which will be determined by biological effect of the drug (measured in patient peripheral blood samples) and levels of toxicity (measured by adverse event reporting). The final dose per strata will be that which ac
Phase II
Drug / Intervention This is an open label, Phase II, multicentre study evaluating the anti-tumour activity of continuous, low dose of panobinostat in patients with refractory solid tumours stratified by primary histology into osteosarcoma, malignant rhabdoid tumour/atypical teratoid rabdoid tumour (MRT/ATRT). and neuroblastoma.
Sponsor Australian and New Zealand Children’s Haematology and Oncology Group (ANZCHOG)
Australasian Sarcoma Study Group
Funding Source
Target accrual
Expected Completion 7/03/2022
Participating Sites
Recruitment Status Recruiting
Numbers Accrued
Publications and Presentations
 
Principal Investigator Dr Jayesh Desai
Contact for Further Information https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374371

Dr Jayesh Desai
Contact Phone Number +61 3 8559 7379
Last update 22-Nov-2018 01:55 PM 

 

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