A Phase I/II Study of CX5461

Official Title

A Phase I/II Study of CX5461

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.

Trial Description

Primary Outcome:

  • Phase I: Confirm the recommended phase II dose and schedule of CX5461 in patients with solid tumours
  • Phase 2: Measure anti-tumour activity assessed by response rate (RR) using RECIST in each cohort
Secondary Outcome:
  • Phase I and 2: Number and severity of adverse events in patients
  • Phase I: Assess pharmacokinetics of CX5461
  • Phase 2: Estimate the progression free survival (PFS) rate
The purpose of the first phase of this study (phase I) 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. The purpose of the second phase of this study (phase II) is to find out what effects a new drug, CX5461, has on you and your breast cancer.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society