Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ZD4054 (Zibotentan), Zibotentan
ZD4054 · 8 trials · 7 indications
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)
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.
DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.
| 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 |
| 1 | EXPERIMENTAL | ZD4054 + Pemetrexed |
| 2 | PLACEBO_COMPARATOR | ZD4054 matched placebo + pemetrexed |
| 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 |
| ZD4054 22.5 mg | EXPERIMENTAL | 2 x 10 mg + 1 x 2.5 mg oral tablets once daily |
| 3 | EXPERIMENTAL | Moderate Hepatic Impairment |
| 4 | EXPERIMENTAL | Severe Hepatic Impairment |
| 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 |
| Pemetrexed | DRUG | 500mg2/m IV infusion |
| ZD4054 15 mg | DRUG | 15 mg oral tablet once daily |
| ZD4054 10 mg | DRUG | 10mg oral tablet once daily |
| ZD4054 22.5 mg | DRUG | 2 x 10 mg + 2 x 2.5 mg oral tablets once daily |
| ZD4054 (Zibotentan) | DRUG | 10 mg ZD4054 (Zibotentan) once daily on Day1, Day4 to Day15 |
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...
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ZD4054, also known as zibotentan, is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for oncology indications. It has been studied in advanced solid malignancies, non small cell lung cancer, prostate cancer, prostatic neoplasms, and in subjects with hepatic impairment. It is not an approved therapy and remains in clinical development.
ZD4054 has been studied in metastatic hormone resistant prostate cancer, including a Phase III trial combining it with docetaxel that enrolled 1,494 male patients across many countries. It has also been evaluated in non small cell lung cancer and advanced solid malignancies. ZD4054 is investigational and is not an approved treatment.
ZD4054, or zibotentan, is an endothelin A receptor antagonist. It targets the endothelin A receptor, which is the mechanism described in its clinical trial titles, including a Phase III study in metastatic hormone resistant prostate cancer. This receptor target distinguishes it as a small molecule oncology agent.
ZD4054 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trials of zibotentan, including studies in prostate cancer, non small cell lung cancer, advanced solid malignancies, and hepatic impairment. The drug remains an AstraZeneca investigational asset.
ZD4054 has completed Phase 1, Phase 2, and Phase 3 trials, with no active trials currently listed. The Phase 3 study was in metastatic hormone resistant prostate cancer. Because it is not approved, ZD4054 is considered investigational and is not available as a marketed therapy.
ZD4054 has been evaluated in four completed trials: NCT00997945, a Phase 1 pharmacokinetic study in Chinese patients with advanced solid malignancies; NCT00745875, a Phase 2 non small cell lung cancer study; NCT00672581, a Phase 1 hepatic impairment study; and NCT00617669, a Phase 3 prostate cancer trial. All are completed.
Yes, ZD4054 is the same as zibotentan. ZD4054 is the compound code, and zibotentan is the international nonproprietary name. The trial titles also refer to ZD4054 10 mg and ZD4054 15 mg dose strengths. All these names refer to the same AstraZeneca investigational endothelin A receptor antagonist.