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RecruitingLast updated:15 August 2023

PETRA: This Phase I/II trial is trying to determine how safe, tolerable and effective a targeted cancer drug (AZD5305) is alone, or in combination with chemotherapy (paclitaxel and carboplatin) in people with advanced solid cancersA 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

Clinical summary

Summary

This is a non-randomised trial with 3 experimental arms. Each arm has two parts: Part A is dose escalation, and Part B is an expansion. Participants in Experimental Arm 1 will receive AZD5305 monotherapy (orally). In Experimental Arm 2, participants will receive AZD5305 (orally) in combination with Paclitaxel (intravenously). In Experimental Arm 3, participants will receive AZD5305 (orally) + Carboplatin with or without Paclitaxel (intravenously).

Treatment Type

Radiotherapy

Age

People18 - 130

Phase

I/II

Trial Acronym

PETRA

More information

Trial Identifiers

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Commercial Sponsor

AstraZeneca

Scientific 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

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
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Clinical trials have complex eligibility criteria.

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