Clinical Trials /

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

NCT02792465

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors
  • Official Title: An Open Label, Dose Escalation, Safety, and Pharmacokinetic Study of CFI-402257 Administered Orally to Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CFI-402257-CL-001
  • NCT ID: NCT02792465

Conditions

  • Advanced Solid Cancers

Interventions

DrugSynonymsArms
CFI-402257CFI-402257

Purpose

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 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.
    

Trial Arms

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

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  Women who are pregnant or nursing.

          -  Have received radiotherapy (patients having limited field palliative radiotherapy less
             than 2 weeks), chemotherapy, biological therapy, or investigational treatment less
             than four weeks (six weeks for nitrosoureas or mitomycin C) prior to first dose of
             study drug or have not recovered from all acute toxicities from prior treatments and
             those deemed by the Investigator not to affect safety assessment.

          -  Patients who have received growth factors within 14 days prior to initiation of dosing
             of CFI-402257 or who will require ongoing treatment with growth factors throughout the
             duration of the trial.

          -  Have active, acute, or clinically significant chronic infections.

          -  Have uncontrolled severe hypertension.

          -  Have symptomatic congestive heart failure.

          -  Have active angina pectoris or recent myocardial infarction (within 6 months).

          -  Have chronic atrial fibrillation or QTc of greater than 470 msec.

          -  Have had major surgery within 21 days of starting therapy.

          -  Have additional uncontrolled serious medical or psychiatric illness.

          -  Have any medical condition that would impair the administration of oral agents
             including significant bowel resection, inflammatory bowel disease or uncontrolled
             nausea or vomiting.

          -  Known central nervous system metastasis.

          -  Patients being treated with full dose warfarin are excluded.

          -  Patients being treated with the following drugs are excluded: Alfentanil, Pimozide,
             Cyclosporine, Quinidine, Digoxin, Sirolimus, Dihydroergotamine, Tacrolimus,
             Ergotamine, Warfarin, Fentanyl.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03
Time Frame:2 years
Safety Issue:
Description:
Measure:Treatment-emergent changes in vital signs
Time Frame:2 years
Safety Issue:
Description:
Measure:Treatment-emergent changes in clinical laboratory tests from baseline values obtained prior to treatment
Time Frame:2 years
Safety Issue:
Description:
Measure:Treatment-emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), at periodic intervals during the study and at End of Treatment
Time Frame:2 years
Safety Issue:
Description:
Measure:Area under the plasma concentration-time curve (AUC)
Time Frame:2 years
Safety Issue:
Description:
Measure:Elimination half-life (T½)
Time Frame:2 years
Safety Issue:
Description:
Measure:Maximum plasma concentration (Cmax)
Time Frame:2 years
Safety Issue:
Description:
Measure:Minimum plasma concentration (Cmin)
Time Frame:2 years
Safety Issue:
Description:
Measure:Time when Cmax occurs (Tmax)
Time Frame:2 years
Safety Issue:
Description:
Measure:Average plasma concentration at steady state (Cavg)
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University Health Network, Toronto

Last Updated

May 20, 2019