A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
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 Maximum Tolerable
Dose has been established, up to a total of 20-40 patients with Soft Tissue Sarcoma 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.