Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EpothiloneZK, ZK 219477, Sagopilone
ZK-EPO · 10 trials · 10 indications
Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
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 | PLACEBO_COMPARATOR | - |
| Chemotherapy - ZK-EPO | EXPERIMENTAL | ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m\^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity. |
| 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, 0.5 h infusion | EXPERIMENTAL | Subjects received one infusion (for 0.5 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks |
| Sagopilone, 3 h infusion | EXPERIMENTAL | Subjects received one infusion (for 3 h) of sagopilone every 3 weeks at a dose of 16 mg/m2 (maximum up to 32 mg) for approximately 18 weeks |
| Sagopilone and cisplatin | EXPERIMENTAL | The study drug sagopilone was administered in combination with a fixed dose of cisplatin |
| 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. |
| Name | Type | Description |
|---|---|---|
| Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid | DRUG | Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. In addition, subjects will receive Acetyl-L-Carnitine (ALC) 1000 mg tid. Treatment with Sagopilone and ALC will be continued as long as there is benefit. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone. |
| Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid | DRUG | Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment will be continued as long as there is benefit. In addition, subjects will receive 21 weeks of placebo 1000 mg tid. After all patients have completed 6 cycles of treatment, an analysis will be performed to see whether ALC was better than placebo. If this is the case, patients still under placebo treatment will be offered to switch to ALC. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone. |
| ZK-EPO | DRUG | Participants were treated with 16 mg/m\^2 of ZK-EPO (EpothiloneZK) (Sagopilone) administered as a single 3 hour intravenous infusion every 21 days. Prior to each treatment, participants were premedicated with either granisetron or ondansetron and additional anti-emetics if needed. Chemotherapy was continued until disease progression, withdrawal of consent, or for unacceptable treatment-associated toxicity. |
| Sagopilone (ZK 219477) + carboplatin | DRUG | Chemotherapy for recurrent ovarian cancer |
| Sagopilone (ZK 219477) + prednisone | DRUG | Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity. |
| 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 (BAY86-5302 , ZK219477) | DRUG | 10.5 mg lyophilized sagopilone per vial |
| Cisplatin | DRUG | 75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1 |
| 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. |
Inclusion Criteria: * Males or females aged \>/= 18 years * Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or clear cell tumors) or Adenocarcinoma of the prostate * At least 1 unidimensional measurable lesion (suitable for RECIST evaluation) or for patients without ...
Top 20 of 50 competitors