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A Modular, Multi-arm, Multi-part, Phase 1/2a, Adaptive Design Study to Evaluate the Safety and Tolerability of RXC004, Alone and in Combination With Other Anti Cancer Treatments, in Patients With Advanced Malignancies

Trial Profile

A Modular, Multi-arm, Multi-part, Phase 1/2a, Adaptive Design Study to Evaluate the Safety and Tolerability of RXC004, Alone and in Combination With Other Anti Cancer Treatments, in Patients With Advanced Malignancies

Suspended
Phase of Trial: Phase I/II

Latest Information Update: 23 Dec 2018

At a glance

  • Drugs RXC 004 (Primary)
  • Indications Biliary cancer; Cancer; Colorectal cancer; Gastric cancer; Pancreatic cancer
  • Focus Adverse reactions; First in man
  • Sponsors Redx Pharma
  • Most Recent Events

    • 04 Sep 2018 According to a Redx Pharma media release, announces that having presented an amended study protocol to the Medicines and Healthcare products Regulatory Agency (MHRA, the Agency), the Agency has agreed, in principle, with the proposed re-start of the Companys phase 1/2a clinical study for the Porcupine inhibitor, RXC004. Redx will now work with the investigators to finalise this protocol, with the intention of restarting dosing of patients in the first half of 2019.
    • 30 May 2018 According to a Redx Pharma media release, company expect to enrol additional patients into the amended phase I/IIa clinical trial early next year.
    • 29 Mar 2018 According to a Redx Pharma media release, the Company has suspended recuritment of further patients in the trial as clinically significant adverse events were observed in the first patient dosed with RXC-004. The Company intends to propose a protocol amendment that enables dose-escalation to re-start at significantly lower dose levels. This protocol amendment will be finalised with consultation with both the MHRA and principal investigators.
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