A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors (NCT02792465) | Clinical Trial Compass
CompletedPhase 1
A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors
Canada52 participantsStarted 2016-11-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria - Cohort A:
* Have histological or cytological proof of advanced cancer that has progressed and for which there is no further standard anticancer therapy available in the opinion of the Investigator.
* Patients must have measurable disease as per RECIST v 1.1 guidelines.
* Patients must be ≥18 years of age.
* Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Be able to swallow oral medications.
* Have a life expectancy of greater than 3 months.
* Women and men of child-producing potential must agree to use highly effective means of contraception for a specified period.
* A negative serum pregnancy test for women of childbearing potential.
* Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, provide archived tissue if available for biomarker studies, provide a blood sample for genetic testing and agree to return for the required assessments.
Inclusion Criteria - Cohort B:
* Have histologically and/or cytologically confirmed diagnosis of breast cancer that is advanced/metastatic/recurrent or unresectable, for which no curative therapy exists.
* Patients must have had at least 1 but not more than 4 prior lines of cytotoxic chemotherapy for brea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort