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Also known as Patupilone
Patupilone and Omeprazole · 11 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 | - |
| Patupilone and Omeprazole | EXPERIMENTAL | patupiloe + omeprazole |
| patupilone + midalzolam | EXPERIMENTAL | patupilone + midalzolam |
| 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 and Omeprazole | DRUG | - |
| Patupilone + Midalzolam | 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 and Omeprazole refers to a clinical study combining patupilone, an investigational small molecule oncology agent, with omeprazole. Patupilone is also known as EPO906. The combination has been studied in Phase 1 trials in patients with advanced malignancies and advanced solid tumors. It is not an approved therapy.
Patupilone has been studied in Phase 1 clinical trials for advanced malignancies and advanced solid tumors, including non-small-cell lung carcinoma, hepatocellular carcinoma, metastatic hormone refractory prostate cancer, and brain metastasis. These studies evaluated the drug in adult patients with advanced disease. Patupilone remains investigational and is not approved for any indication.
Patupilone targets tubulin proteins, specifically TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as a tubulin stabiliser, binding to and stabilising microtubules. This mechanism interferes with microtubule dynamics, which are essential for cell division, thereby inhibiting tumor cell proliferation.
Patupilone is developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the Phase 1 clinical program evaluating patupilone, including its combination with omeprazole, across multiple advanced solid tumor settings. The compound is also referenced by the ChEMBL identifier CHEMBL94657.
Patupilone is in Phase 1 clinical development. All four recorded trials of patupilone were Phase 1 studies, and all four have been completed. The drug is investigational and has not been approved by the FDA for any indication. No active trials are currently listed for patupilone.
Four completed Phase 1 trials have evaluated patupilone: NCT00448396 studied its effects on warfarin pharmacokinetics in advanced malignancies, NCT00426582 tested patupilone with carboplatin in advanced solid tumors, NCT00426140 assessed pharmacokinetics after single intravenous administration, and NCT00421044 studied patients with varying degrees of hepatic function. Total enrollment across these trials was 185 patients.
Yes, patupilone is also known as EPO906. Both names refer to the same investigational small molecule tubulin stabiliser developed by Novartis AG. Patients and researchers may encounter either name in clinical trial records and scientific literature describing the Phase 1 studies in advanced solid tumors and advanced malignancies.