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

Titre officiel

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

Sommaire:

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.

Description de l'essai

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:
  • 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
  • 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 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)
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.

Voir cet essai sur ClinicalTrials.gov

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