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Recruiting
NCT07590934
Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer
Conditions: Metastatic Prostate Cancer
Sex: Male
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 152
Sponsor: AstraZeneca
Location: Research Site Encino California
Summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.
Eligibility Criteria
Inclusion Criteria:
1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).
2. Minimum life expectancy of 3 months or more.
3. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
4. PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
5. Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.
6. Must have one or more unresectable metastatic lesions.
7. Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (\
Source: ClinicalTrials.gov (NCT07590934). StuddyBuddy aggregates publicly available trial information.
