ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer. The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib.
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Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
Timeframe: From first dose of study intervention to 28 days post first dose
Number of participants with Adverse Events and Serious Adverse Events
Timeframe: From first dose of study intervention up to 37 days after the last dose of study treatment
Number of participants with Adverse Events leading to discontinuation of study intervention
Timeframe: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in vital signs.
Timeframe: From first study dose up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in physical examination.
Timeframe: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in ECOG PS.
Timeframe: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in ECGs.
AstraZeneca Clinical Study Information Center
Timeframe: From first dose of study intervention up to 37 days after the last dose of study treatment
Clinically significant changes from baseline in laboratory parameters.
Timeframe: From first dose of study intervention up to 37 days after the last dose of study treatment
Proportion of participants achieving a ≥50% decrease in PSA from baseline (PSA50) (Part B only)
Timeframe: From first dose of study intervention up to 14 days after the last dose of study treatment