Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA)
Sponsor: AstraZeneca + Bayer
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of patients with Adverse Events and Serious Adverse Events
Time frame: Up to post treatment follow-up (28 days after last dose) [assessed up to 2.3 years]
Part A: Number of patients with Dose Limiting Toxicities (DLTs)
Time frame: For Arm 1: 35 days, For Arm 2 and 3: 28 days
Secondary Endpoints
Area Under the concentration Curve (AUC) of AZD5305
Maximum plasma concentration (Cmax) of AZD5305
Time to maximum concentration (tmax) of AZD5305
Eligibility Criteria
Inclusion Criteria: For whole study: * Age ≥ 18 at the time of screening. * Histologically confirmed diagnosis of metastatic prostate cancer. * Candidate for treatment with enzalutamide, abiraterone acetate, darolutamide or apalutamide with documented current evidence of metastatic prostate cancer. * Surgically or medically castrated. * Adequate organ and marrow function. * Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 with no deterioration over the previous 2 weeks. * Life expectancy ≥ 16 weeks. * Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to approximately 6 months after the last dose of study treatment . For Patients Recruited Specifically to tumour Pharmacodynamic Cohorts: • Patients must have at least 1 tumour suitable for paired biopsies For Part A: • Patients with Metastatic Castrate ion-Resistant Prostate Cancer (mCRPC) or Metastatic Castration …
Read full criteria on CT.gov →✦ Analyst Commentary
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