A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumours

Official Title

An Open Label, Dose Escalation, Safety, and Pharmacokinetic Study of CFI-402257 Administered Orally to Patients With Advanced Solid Tumours

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.

Trial Description

Primary Outcome:

• Highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort

Secondary Outcome:

• Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03
• Treatment-emergent changes in vital signs
• Treatment-emergent changes in clinical laboratory tests from baseline values obtained prior to treatment
• Treatment-emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), at periodic intervals during the study and at End of Treatment
• Area under the plasma concentration-time curve (AUC)
• Elimination half-life (T½)
• Maximum plasma concentration (Cmax)
• Minimum plasma concentration (Cmin)
• Time when Cmax occurs (Tmax)
• Average plasma concentration at steady state (Cavg)

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 tumours 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 tumours 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.

View this trial on ClinicalTrials.gov