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

Titre officiel

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

Sommaire:

Il s’agit d’une étude de phase I portant sur l’agent expérimental CFI-402257 administré à des patients atteints de cancers au stade avancé. Le but de cette étude est de vérifier dans quelle mesure le CFI-402257 est sûr et tolérable chez les patients atteints de cancer, de même que d’établir les paramètres pharmacocinétiques de cet agent. Dans le cadre de cette étude, le CFI-402257 est administré pour la première fois à des humains.

Description de l'essai

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 will have two parts: dose escalation and dose expansion. The dose escalation part will test 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). 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.

Voir cet essai sur ClinicalTrials.gov

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