CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer

Official Title

A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination With Weekly Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer

Summary:

The standard or usual treatment for this disease is to undergo chemotherapy to slow the spread of disease and relieve some symptoms of cancer. One of the standard types of chemotherapy is a drug called paclitaxel (Taxol) given in a low dose every week for three out of four weeks. CFI-402257 is a new type of drug for breast cancer. Laboratory tests show that it may help slow the growth of breast cancer. This drug has been shown to shrink tumours in animals. CFI-402257 has been studied in a few people and appears well tolerated with little side effects. CFI-402257 seems promising but it is not clear if it can offer better results when given with paclitaxel compared to paclitaxel alone.

Trial Description

Primary Outcome:

  • Phase I: Safety and tolerability of CFI-402257 assessed by CTCAE
  • Phase I: Identify the recommended phase II dose
  • Phase II: Overall Response Rate using RECIST 1.1
Secondary Outcome:
  • Clinical benefit rate determined by complete response, partial response or stable disease
  • Number and severity of adverse events by CTCAE
  • Pharmacokinetic analysis (AUC) using ANOVA and linear regression or comparable nonparametric statistical methods will be used to make dose group comparisons.
  • Pharmacokinetic analysis (Cmax) using ANOVA and linear regression or comparable nonparametric statistical methods will be used to make dose group comparisons.

Phase I: The purpose of the first phase of the study is to find the highest dose of CFI-402257 that can be tolerated without causing very severe side effects when receiving paclitaxel. This is done by starting at a dose lower than the one that is tolerated in patients when given on its own. Participants are given CFI-402257 together with paclitaxel and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then new participants will be given a higher dose of CFI-402257. Participants joining this study later on will get higher doses of CFI-402257 than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Phase II: The purpose of the second phase will be to find out the effect that CFI-402257 has on breast cancer, using doses found to be safe in the first phase of the study, when given with paclitaxel.

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