A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas
This trial is an open-label, multicentre, dose-escalation Phase I/II study to evaluate
safety, efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with
doxorubicin administered q 3 weeks in patients with advanced solid tumours. Once the MTD has
been established, up to a total of 20-40 patients with STS may be enrolled at the MTD dose
level to examine efficacy and safety in this specific patient population. The trial is
stopped if no more than 2 responses are seen among the first 20 of these patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT)) and efficacy of PXD101 and doxorubicin combination treatment measured by response rate using the RECIST response criteria.
Ole Steen Nielsen, MD
Århus Hospital, Department of Oncology
United States: Food and Drug Administration