A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid CancersBreast Cancer
- Interventions
- Registration Number
- NCT02792465
- Lead Sponsor
- University Health Network, Toronto
- Brief 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.
- Detailed Description
CFI-402257 is an oral drug that blocks TTK protein kinase (also known as Monopolar spindle 1 \[Mps1\]) activity. TTK is a protein that is important in regulating cell growth, and cell death, and ensuring proper division. Many tumors are shown to make too much TTK. When there is too much TTK produced, it is believed to contribute to uncontrolled cancer cell growth and division leading to additional mutations in cancer cells. Therefore, it is believed that blocking this protein from working will lead to cancer cell death, stopping tumors from growing or shrinking them.
This study has two parts: dose escalation and dose expansion.
The dose escalation part tested different dose levels of study drug in groups of patients to find the highest dose of study drug that can be given safely to patients (called maximum tolerated dose or MTD). This part of the study is now complete.
The expansion part will further assess the safety, tolerability, and PK of the MTD found in the escalation part of the study in additional group of patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort C CFI-402257 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 Cohort A CFI-402257 CFI-402257 capsules will be taken orally, once a day, every day. Cohort B CFI-402257 CFI-402257 capsules will be taken orally, once a day, every day. Cohort C Fulvestrant 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
- Primary Outcome Measures
Name Time Method Highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort 2 years
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03 2 years Area under the plasma concentration-time curve (AUC) 2 years Minimum plasma concentration (Cmin) 2 years Time when Cmax occurs (Tmax) 2 years Average plasma concentration at steady state (Cavg) 2 years Treatment-emergent changes in vital signs 2 years Treatment-emergent changes in clinical laboratory tests from baseline values obtained prior to treatment 2 years Treatment-emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), at periodic intervals during the study and at End of Treatment 2 years Elimination half-life (T½) 2 years Maximum plasma concentration (Cmax) 2 years
Trial Locations
- Locations (3)
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
BC Cancer Agency🇨🇦Vancouver, British Columbia, Canada