Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Patupilone · 10 trials · 9 indications
The MTD was defined as the highest dose of patupilone administered every three weeks (q3w) where not more than one out of six patients experienced a DLT using a standard 3+3 design. Dose escalation started at 6.5 mg/m\^2 until MTD in steps of 0.5 mg/m\^2 until 12 mg/m\^2, then in steps of 1 mg/m\^2 till 13.0 mg/m\^2. DLTs were assessed during cycle 1. During this time frame, no more than one DLT occurred in any of the explored dose levels up to 13 mg/m\^2, thus, the MTD as defined by the protocol was not reached in this study.
Overall response is the number of participants who had a complete response (CR) or a partial response (PR) based on local investigator's assessment of RECIST criteria. Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.
| Arm | Type | Description |
|---|---|---|
| 1: 8 mg/m2 study drug + prednisone | EXPERIMENTAL | Patupilone 8 mg/m2 + prednisone 5 mg bid daily |
| 2: study drug + prednisone days 1 -8 | EXPERIMENTAL | Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid |
| 3: Study drug + prednisone days 1 - 4 | EXPERIMENTAL | Patupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid |
| 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily | ACTIVE_COMPARATOR | Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily |
| Patupilone | EXPERIMENTAL | was administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks |
| Single Arm | EXPERIMENTAL | - |
| EPO906 | EXPERIMENTAL | - |
| Patupilone only | EXPERIMENTAL | Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin |
| Carboplatin alone | ACTIVE_COMPARATOR | Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin |
| Arm A (Normal liver function) | EXPERIMENTAL | - |
| Arm B (Mild liver dysfunction) | EXPERIMENTAL | - |
| Arm C (Moderate liver dysfunction) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Patupilone | DRUG | - |
| prednisone | DRUG | - |
| docetaxel | DRUG | - |
| Patupilone/EPO906 | DRUG | - |
Inclusion criteria: * Must be ≥ 18 years of age * Confirmed and documented diagnosis of prostate cancer * Confirmed and documented evidence of progression of disease (hormone refractory) * Low testosterone levels * Chemotherapy-naïve Exclusion criteria: * Recent radiation therapy (within 4 weeks)...
Patupilone is an investigational small molecule being studied in oncology for several advanced cancers, including metastatic hormone refractory prostate cancer, advanced solid tumors, brain metastasis, carcinoma, and non-small-cell lung cancer. It is developed by Novartis AG and is currently in Phase 1 clinical development.
Patupilone is a small molecule in oncology. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not detailed here. It is being investigated for its potential effects in advanced malignancies and solid tumors.
Patupilone is developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 1 clinical trials for various oncology indications.
Patupilone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All four clinical trials for Patupilone have been completed, with no active trials currently ongoing.
Patupilone has completed four Phase 1 clinical trials: NCT00420524 and NCT00421044 studied the drug in patients with advanced solid tumors and varying degrees of hepatic function; NCT00426140 examined its pharmacokinetics after a single intravenous administration; and NCT00448396 evaluated its effects on warfarin pharmacokinetics and pharmacodynamics in advanced malignancies.
Patupilone is also known as epothilone B, a natural product derived from the myxobacterium Sorangium cellulosum. It is being developed by Novartis AG as an anticancer agent and is currently in Phase 1 clinical trials for advanced solid tumors and other malignancies.