CFI-402257 + Fulvestrant for Solid Tumors

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byPhilippe Bedard

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

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.

Research Team

Philippe Bedard

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

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

I am fully active or can carry out light work.

Cohort C: Must have a life expectancy of greater than 3 months

Cohort A: Must have measurable disease as per RECIST v 1.1 guidelines

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Exclusion Criteria

I have symptoms of heart failure.

I have ongoing chest pain or had a recent heart attack.

I have a long-term irregular heartbeat or a prolonged QT interval.

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Treatment Details

Interventions

CFI-402257 (Other)

Trial OverviewThe study tests CFI-402257's safety, tolerability, and how the body processes it. It's a phase 1 trial which means this drug is being given to humans for the first time. Patients will also receive Fulvestrant, an existing cancer treatment.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment2 Interventions

CFI-402257 capsules will be taken orally, once a day, every day + Fulvestrant injection on day 1 and day 15 of every 28 day cycle

Group II: Cohort BExperimental Treatment1 Intervention

CFI-402257 capsules will be taken orally, once a day, every day.

Group III: Cohort AExperimental Treatment1 Intervention

CFI-402257 capsules will be taken orally, once a day, every day.