Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZD4054 · 12 trials · 9 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 | ZD4054 + ZD4054 placebo + Moxifloxacin placebo |
| 4 | PLACEBO_COMPARATOR | ZD4054 Placebo + Moxifloxacin placebo |
| 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 |
| midazolam | DRUG | - |
| Moxifloxacin | DRUG | 400 mg capsule |
| ZD4054 Placebo | DRUG | 3 tablets |
| Moxifloxacin placebo | DRUG | 1 capsule |
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...
Top 20 of 53 competitors
ZD4054, also known as zibotentan, is an investigational small molecule being studied in oncology. Clinical trials have evaluated it in healthy volunteers and in patients with prostate cancer, advanced solid malignancies, and non-small cell lung cancer. It is not approved and remains in clinical development.
ZD4054 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of this investigational small molecule in oncology indications.
ZD4054 is in Phase 1 clinical development. All four completed trials were Phase 1 studies, primarily in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
ZD4054 has completed four Phase 1 trials: NCT00709553, a drug interaction study in healthy subjects in Germany; NCT00710047, a food effect study in the UK; NCT00713336, a QTc interval study in the UK; and NCT00713791, a relative bioavailability study in the US.
Yes, ZD4054 is also known as zibotentan. Clinical trial records use both names interchangeably, with titles such as 'Drug Interaction Study to Assess Multiple Doses of ZD4054 (Zibotentan)'.