NCT02719977

A Phase I Study of CX5461

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CX5461 is a new type of drug for many types of cancer, particularly cancers that cannot easily repair damage to their cells. This may help to slow down the growth of cancer or may cause cancer cells to die. CX5461 has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment.

Detailed description

The purpose of this study is to find the dose of a new therapy, CX5461, that can be tolerated without causing very severe side effects and to see what effects the study drug has this cancer. Participants are given CX5461 and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If serious side effects are seen in patients at the first dose level, doses of CX5461 may be lowered in subsequent patients. If the side effects are not serious, then more participants are asked to join this study and are given higher doses. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	CX5461

Timeline

• Start date: 2016-06-13
• Primary completion: 2020-01-30
• Completion: 2023-01-18
• First posted: 2016-03-25
• Last updated: 2023-08-04

Locations

3 sites across 1 country: Canada