Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PXD101 · 1 trial · 2 indications
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...
PXD101 is an investigational small molecule being studied in oncology. It was evaluated in a Phase I/II clinical trial in combination with doxorubicin in patients with soft tissue sarcomas, with a dose escalation phase in solid tumors. The drug is in early clinical development and is not approved.
PXD101 is being developed by Assertio Holdings, Inc., a company traded on NASDAQ under the ticker ASRT. The drug is an investigational small molecule in Phase 1 clinical development for oncology indications.
PXD101 is in Phase 1 clinical development. It has completed one Phase I/II trial that included a dose escalation phase for solid tumors and a maximum tolerated dose phase for soft tissue sarcomas. The drug remains investigational and has not been approved.
PXD101 has been studied in one completed clinical trial, NCT00878800, titled "A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas." The trial enrolled 41 participants and was conducted in Denmark and the United Kingdom.
Yes, PXD101 has been studied in combination with doxorubicin. The completed Phase I/II trial, NCT00878800, evaluated this combination in patients with soft tissue sarcomas, including a dose escalation phase for solid tumors. The trial was uncontrolled and not randomized.