NCT03568422

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	CFI-402257	Orally taken on intermittent schedule (days 1, 2, 8, 9, 15 \& 16
DRUG	Paclitaxel	80 mg/m2 IV days 1, 8 \& 15 every 28 days

Timeline

• Start date: 2019-02-05
• Primary completion: 2022-11-21
• Completion: 2026-12-31
• First posted: 2018-06-26
• Last updated: 2026-03-27
• Results posted: 2024-06-26

Locations

4 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study