Conditions: Dose Escalation: Solid Tumors MTD: Soft Tissue Sarcomas
Keywords: Phase I/II trial Solid tumors Soft tissue sarcoma PXD101 Doxorubicin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 5-day PXD101 IV schedule with dose escalation combined with 1 day doxorubicin dose escalation IV

Interventions: intervention 1: PXD101 intervention 2: Doxorubicin
Intervention descriptions: intervention 1: Administered in combination with doxorubicin (BelDox) intervention 2: Administered in combination with PXD101 (BelDox)

Protocol document: