A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.

  • STATUS
    Not Recruiting
  • End date
    Feb 26, 2024
  • participants needed
    192
  • sponsor
    AstraZeneca
Updated on 19 August 2022
oophorectomy
antineoplastic

Summary

This is a modular Phase I/IIa, open-label, multi-centre, study of AZD7648 administered orally, either as a monotherapy, or in combination with either cytotoxic chemotherapies or novel anti-cancer agents in participants with advanced malignancies.

Description

The modular design allows for an escalation of the dose of AZD7648 alone or in combination with either cytotoxic chemotherapies or novel anti-cancer agents, with intensive safety monitoring to ensure the safety of the participants.

The study consists of 2 modules each evaluating the safety and tolerability of AZD7648 monotherapy or with a specific combination partner.

Core module of the study is dose escalation (Part A) of AZD7648 monotherapy, administered orally, in participants with advanced solid tumours.

Combination module 1 has 2 study parts: Part A consisting of dose escalation cohorts and Part B, a safety and proof of concept Phase IIa expansion. A Safety Review Committee will review evaluable participants at each cohort and assess if the study should progress to Part B.

Details
Condition Advanced Malignancies
Treatment olaparib, Pegylated Liposomal Doxorubicin (PLD), PLD, AZD7648
Clinical Study IdentifierNCT03907969
SponsorAstraZeneca
Last Modified on19 August 2022

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