Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Official Title

A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Summary:

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumours.

Trial Description

Primary Outcome:

• The number of subjects with adverse events/serious adverse events
• The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.

Secondary Outcome:

• Best percentage change in target lesion
• Objective Response Rate
• Duration of Response
• Progression Free Survival
• Time To Response
• Effects of AZD5305 on Ph2AX (Ser139) PD biomarker
• CA125 response (ovarian cancer)
• Module 1: Area Under Curve (AUC)
• Module 1: Maximum plasma concentration of the drug (Cmax)
• Module 1: The time taken to reach the maximum concentration (Tmax)
• Module 1 and Module 5: Objective Response Rate (prostate cancer)
• Module 1: Radiographic progression free survival (prostate cancer)
• Module 1: Proportion of subjects with ≥ 50% PSA decrease (prostate cancer)
• Module 2: Area Under Curve (AUC)
• Module 2: Maximum plasma concentration of the drug (Cmax)
• Module 2: The time taken to reach the maximum concentration (Tmax)
• Module 3: Area Under Curve (AUC)
• Module 3: Maximum plasma concentration of the drug (Cmax)
• Module 3: The time taken to reach the maximum concentration (Tmax)
• Module 4 : Area Under Curve
• Module 4: Maximum plasma concentration of the drug (Cmax)
• Module 4: The time taken to reach the maximum concentration (Tmax)
• Module 4: Anti-Drug Antibody (ADA)
• Module 5: Area Under Curve
• Module 5: Maximum plasma concentration of the drug (Cmax)
• Module 5: The time taken to reach the maximum concentration (Tmax)
• Module 5: Anti-Drug Antibody (ADA)
• Module 1 : To investigate the effect of a high-fat meal on the PK of AZD5305

This study is a Phase I/IIa modular, open-label, multi-centre study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.

View this trial on ClinicalTrials.gov