Pharmacokinetics, Clinical Trial
Official title:
A Phase Ib Multicentre Study of AZD5363 Monotherapy to Assess Anti-Tumour Activity,Safety,Tolerability,and Pharmacokinetics in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC)(PYRUS)
To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy,
in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated
in patients who have progressed after chemotherapy (Part A) and in patients who have
progressed before receiving chemotherapy (Part B).
Recruitment into Part A, Group 1 has been suspended. A new design for this group is
currently being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd
generational anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days
on/3days off).
Part B will only start if there is evidence of anti-tumour activity along with AZD5363
having an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy
patients on a dose and schedule selected from Part A.
A Phase Ib Multicentre Study of AZD5363 Monotherapy to Assess Anti-Tumour Activity, Safety, Tolerability, and Pharmacokinetics in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (PYRUS) ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01735240 -
Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.
|
Phase 1 |