Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3514 · 2 trials · 1 indication
Number of participants with adverse events
| Arm | Type | Description |
|---|---|---|
| AZD3514 | EXPERIMENTAL | Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD) |
| A | EXPERIMENTAL | Ascending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD) |
| Name | Type | Description |
|---|---|---|
| AZD3514 | DRUG | Patients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout. |
Inclusion Criteria: * Males aged 20 years or older. * Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate * Documented evidence of metastatic prostate cancer * Serum testosterone concentration ≤50 ng/dL * World Health...
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AZD3514 is an investigational small molecule developed for the treatment of prostate cancer. It was studied in Phase 1 clinical trials in adult male patients with prostate cancer. It is not an approved therapy and remains an experimental agent that was evaluated in early-stage clinical research.
AZD3514 targets the androgen receptor, or AR. It is classified as an AR modulator, meaning it acts on androgen receptor signaling. The androgen receptor is a key driver of prostate cancer growth, which is why it was pursued as a therapeutic target in this disease.
AZD3514 was developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 1 clinical trials of the compound in prostate cancer, including studies conducted in Japan and in the United States, the Netherlands, and the United Kingdom.
AZD3514 is in Phase 1. It is an investigational drug and is not FDA approved. Both of its recorded clinical trials were Phase 1 studies, and both are now completed, with no active trials ongoing. It was evaluated in adult male patients with prostate cancer.
AZD3514 was studied in two completed Phase 1 trials: NCT01351688, an open label prostate cancer study in Japanese patients that enrolled 13 participants, and NCT01162395, an open label prostate cancer study that enrolled 64 participants across the United States, the Netherlands, and the United Kingdom. Together these trials enrolled 77 patients.
The two completed Phase 1 trials of AZD3514 enrolled a total of 77 patients. NCT01162395 enrolled 64 participants across the United States, the Netherlands, and the United Kingdom, while NCT01351688 enrolled 13 Japanese patients. Both studies were open label, uncontrolled, and restricted to male patients aged 20 years and older.