Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00878800 | A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas | PHASE1 | COMPLETED | 41 | — | — | Dec 1, 2006 | Oct 1, 2012 | Jul 28, 2015 | 3 | Denmark, United Kingdom |
Maximum Tolerated Dose (MTD) of PXD101treatment
Maximum Tolerated Dose (MTD) of doxorubicin
Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment
Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment.
| Arm | Type | Description |
|---|---|---|
| Experimental: PXD101 and doxorubicin (BelDox) | EXPERIMENTAL | 5-day PXD101 IV schedule with dose escalation combined with 1 day doxorubicin dose escalation IV |
| Name | Type | Description |
|---|---|---|
| PXD101 | DRUG | Administered in combination with doxorubicin (BelDox) |
| Doxorubicin | DRUG | Administered in combination with PXD101 (BelDox) |
Inclusion Criteria: 1. Signed consent of an IEC (Independent Ethics Committee)-approved Information consent form 2. A. For the dose escalation phase: Patients with histological or cytological confirmed solid tumours (including sarcomas), for which there is no known curative therapy B. For the MTD e...