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.
Interventional
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.
2 years
Yes
Ole Steen Nielsen, MD
Principal Investigator
Århus Hospital, Department of Oncology
United States: Food and Drug Administration
PXD101-CLN-14
NCT00878800
December 2006
October 2012
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