Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sagopilone · 5 trials · 6 indications
The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).
Maximum plasma concentration for \[14C\]-ZK 219477, ZK 219477
Time to Cmax for \[14C\]-ZK 219477, ZK 219477
Area under the concentration time curve for \[14C\]-ZK 219477, ZK 219477
AUC from administration until the last time point with measurable concentration for \[14C\]-ZK 219477, ZK 219477
AUC from time zero to 24 hours for \[14C\]-ZK 219477, ZK 219477
Mean residence time for \[14C\]-ZK 219477, ZK 219477
Terminal half-life for \[14C\]-ZK 219477, ZK 219477
Apparent terminal rate constant for \[14C\]-ZK 219477, ZK 219477
Total clearance for ZK 219477
Apparent volume of distribution at steady state for ZK 219477
Apparent volume of distribution during terminal phase for ZK 219477
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4) |
| Arm 4 | EXPERIMENTAL | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4) |
| Sagopilone | EXPERIMENTAL | Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg \[14C\]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n \[till disease progression\]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days. |
| Sagopilone and cisplatin | EXPERIMENTAL | The study drug sagopilone was administered in combination with a fixed dose of cisplatin |
| Name | Type | Description |
|---|---|---|
| Sagopilone (ZK 219477) | DRUG | All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer. |
| Sagopilone (BAY86-5302, ZK 219477) | DRUG | 16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. |
| Sagopilone (BAY 86-5302, ZK 219477) | DRUG | First infusion only: 28 mg, containing 14 kBq/7.8 mcg \[14C\]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min. |
| Cisplatin | DRUG | 75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1 |
Inclusion Criteria: * Metastatic breast cancer (meaning the cancer has spread beyond its original location) * At least one measurable lesion by CT or MRI * Progression of disease following previous therapy for breast cancer * Have received previous treatment with anthracyclines (e.g. doxorubicin\[A...
Sagopilone is an investigational small molecule being studied for the treatment of several cancers, including non-small cell lung cancer, small cell lung cancer, breast cancer, and prostate cancer. It has been evaluated in clinical trials for these oncology indications, though it remains in clinical development and is not approved.
Sagopilone is being developed by Bayer AG, a German pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company has sponsored clinical trials of Sagopilone in oncology indications.
Sagopilone has completed Phase 2 clinical trials for non-small cell lung cancer and breast cancer, and Phase 1 trials for small cell lung cancer and other neoplasms. It is an investigational drug, meaning it has not been approved by regulatory authorities and remains in clinical development.
Sagopilone has been studied in several completed clinical trials. NCT00160069 was a Phase 2 trial in non-small cell lung cancer with 128 participants in Germany. NCT00313248 was a Phase 2 trial in breast cancer with 65 participants in the US and Canada. NCT00359359 was a Phase 1 trial combining Sagopilone with cisplatin in small cell lung cancer, and NCT00432302 was a Phase 1 mass balance study.
Sagopilone is a distinct investigational agent developed by Bayer AG. No alternative names for Sagopilone have been reported. It is a small molecule chemotherapy agent being evaluated for its safety and efficacy in treating various solid tumors, including lung and breast cancers.