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Advanced Solid CancersPhase 1NCT02792465

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

A Phase 1 study testing CFI-402257 and Fulvestrant in people with Advanced Solid Cancers and Breast Cancer, run by University Health Network, Toronto at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Cancers, Breast Cancer
What is being tested?
CFI-402257 and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
3 sitesCanada
Study dates
11 Nov 2016to 12 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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 breast cancer in the advanced/metastatic setting, and must have had prior treatment with an anthracycline and a taxane (unless contraindicated) in either the neo/adjuvant or metastatic setting.
  • Patients must have measurable disease as per RECIST v 1.1 guidelines.
  • Patients must be female.
  • 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 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.
  • Have histological or cytological confirmed diagnosis of breast cancer positive for ER and/or PR and negative for HER2 by ASCO/CAP criteria, that is advanced/metastatic/recurrent or unresectable, for which no curative therapy exists.
  • Patients must have had prior treatment with an aromatase inhibitor in combination with CDK4/6 inhibitor, for a duration of not less than 12 months prior to disease progression. Up to 1 line of cytotoxine chemotherapy in the metastatic setting is allowed.
  • Patients must have measurable disease as per RECIST v 1.1 guidelines.
  • Patients must be female.
  • Patients must be ≥18 years of age.
  • Patients are post-menopausal (including use of ovarian function suppression with LHRH agonist)
  • 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 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.

Who cannot join

  • 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.
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  • 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.
  • Patient who have had prior treatment with a TTK/MPS1 inhibitor
  • For Expanded Cohort C - have previously been treated with, or have a contraindication to treatment with fulvestrant

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
CFI-402257, Fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02792465
Study groupRoleWhat they receive
Cohort AExperimentalCFI-402257 capsules will be taken orally, once a day, every day.
Receives: Drug: CFI-402257
Cohort BExperimentalCFI-402257 capsules will be taken orally, once a day, every day.
Receives: Drug: CFI-402257
Cohort CExperimentalCFI-402257 capsules will be taken orally, once a day, every day + Fulvestrant injection on day 1 and day 15 of every 28 day cycle
Receives: Drug: CFI-402257; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

Secondary outcomes (10)

  1. Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03

    Measured: 2 years

  2. Treatment-emergent changes in vital signs

    Measured: 2 years

  3. Treatment-emergent changes in clinical laboratory tests from baseline values obtained prior to treatment

    Measured: 2 years

  4. Treatment-emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), at periodic intervals during the study and at End of Treatment

    Measured: 2 years

  5. Area under the plasma concentration-time curve (AUC)

    Measured: 2 years

  6. Elimination half-life (T½)

    Measured: 2 years

  7. Maximum plasma concentration (Cmax)

    Measured: 2 years

  8. Minimum plasma concentration (Cmin)

    Measured: 2 years

  9. Time when Cmax occurs (Tmax)

    Measured: 2 years

  10. Average plasma concentration at steady state (Cavg)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2016 (estimated)
  2. Study start11 Nov 2016
  3. Primary completion12 Jun 2025
  4. Study completion12 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Cohort A: Patients with advanced cancer. Treatment: Daily dose of 168 mg of CFI 402257. Cohort B: Patients with advanced breast cancer Treatment: Daily dose of 168 mg of CFI 402257. Cohort C: Patients with breast cancer tested positive for ER and/or PR, and HER2-negative. Treatment: Daily dose of 168 mg of CFI 402257 + Fulvestrant (standard hormonal treatment) on Day 1 and 15 of each 28 day cycle
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02792465
Sponsor's protocol ID
CFI-402257-CL-001
Status last verified
Jun 2026
First submitted
2 Jun 2016
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CFI-402257 and Fulvestrant in people with Advanced Solid Cancers and Breast Cancer, run by University Health Network, Toronto at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02792465.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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