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
Phase of Trial: Phase I/II
Latest Information Update: 06 Apr 2018
At a glance
- Drugs RXC 004 (Primary)
- Indications Cancer; Gastric cancer
- Focus Adverse reactions; First in man
- Sponsors Redx Pharma
- 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.
- 29 Mar 2018 Planned End Date changed from 1 Apr 2019 to 1 Dec 2019.
- 29 Mar 2018 Planned primary completion date changed from 1 Dec 2018 to 1 Jul 2019.