ASSG Endorsed Clinical Study |
NORTH |
| 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 |
