CFI-402257 + Fulvestrant for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a phase 1 study of investigational agent CFI-402257 in patients with advanced cancer. The purpose of this study is to see how safe and tolerable CFI-402257 is in cancer patients as well as the pharmacokinetics (PK). This study is the first time that CFI-402257 is given to humans.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including full dose warfarin and specific drugs like Alfentanil, Pimozide, and others listed in the exclusion criteria. If you are on these medications, you may need to stop them to participate in the trial.
Is the combination of CFI-402257 and Fulvestrant safe for humans?
What makes the drug CFI-402257 unique for treating solid tumors?
What data supports the effectiveness of the drug CFI-402257 + Fulvestrant for solid tumors?
Research shows that Fulvestrant is effective in treating hormone-sensitive breast cancer, especially when combined with other targeted agents, improving outcomes like progression-free survival. While specific data on CFI-402257 is not provided, the combination approach with Fulvestrant has shown promise in similar contexts.1251112
Who Is on the Research Team?
Philippe Bedard
Principal Investigator
Princess Margaret Cancer Centre
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors or breast cancer, where standard treatments no longer work. Participants need to have measurable disease, be in relatively good health (ECOG 0-1), and able to take oral meds. They should expect to live more than 3 months and agree to use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Different dose levels of CFI-402257 were tested to find the maximum tolerated dose (MTD)
Dose Expansion
Further assessment of safety, tolerability, and pharmacokinetics of the MTD in additional patients
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CFI-402257
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor