Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00617669 | A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer | PHASE3 | COMPLETED | 1,494 | — | — | Jan 1, 2008 | Jul 1, 2011 | Sep 10, 2012 | 147 | United States, Argentina +24 |
| NCT00554229 | A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases | PHASE3 | COMPLETED | 896 | — | — | Nov 1, 2007 | Aug 1, 2011 | Feb 8, 2016 | 197 | United States, Argentina +29 |
| NCT00090363 | ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA) | PHASE2 | COMPLETED | 447 | — | — | Jul 1, 2004 | Aug 1, 2011 | Jan 8, 2013 | 60 | United States, Australia +12 |
| NCT00314782 | Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC | PHASE1 | COMPLETED | 44 | — | — | Mar 1, 2006 | Mar 1, 2009 | Mar 12, 2013 | 9 | United States, Germany +1 |
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Placebo + Docetaxel | ACTIVE_COMPARATOR | placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks |
| ZD4054 + Docetaxel | EXPERIMENTAL | ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks |
| ZD4054 | EXPERIMENTAL | ZD4054 10 mg oral tablet once daily |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo, oral tablets once daily |
| ZD4054 10 mg | EXPERIMENTAL | ZD4054 10 mg oral tablet once daily, with best supportive care |
| ZD4054 15 mg | EXPERIMENTAL | ZD4054 15 mg oral tablet once daily, with best supportive care |
| Part A | EXPERIMENTAL | Part A (dose-finding): ZD4054 (Zibotentan) 10 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle |
| Part A (ZD4054 (Zibotentan) 15 mg + docetaxel) | EXPERIMENTAL | Part A (dose-finding): ZD4054 (Zibotentan) 15 mg oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle |
| Part B | EXPERIMENTAL | Part B (randomised, placebo-controlled): ZD4054 (Zibotentan) Maximum Tolerated Dose (MTD), 15mg, oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle |
| Part B (placebo) | EXPERIMENTAL | Part B (randomised, placebo-controlled): Matching placebo oral tablet once daily, with docetaxel 75mg/m\^2 intravenous infusion once per cycle |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | intravenous infusion given every three weeks |
| ZD4054 | DRUG | 10 mg oral once daily dose |
| Placebo | DRUG | placebo oral tablet once daily |
| ZD4054 15 mg | DRUG | 15 mg oral tablet once daily |
| ZD4054 10 mg | DRUG | 10mg oral tablet once daily |
| ZD4054 (Zibotentan) | DRUG | oral tablet |
Inclusion Criteria: Patients who answer TRUE to the following criteria may be eligible to participate in this trial. * Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis) * Increasing Prostate Specific Antigen (PSA), collected withi...