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

NCT02792465 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CFI-402257-CL-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Cancers; Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (10)

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

  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

• Area under the plasma concentration-time curve (AUC)

  2 years

Study Arms (3)

Cohort A

EXPERIMENTAL

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

Drug: CFI-402257

Cohort B

EXPERIMENTAL

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

Drug: CFI-402257

Cohort C

EXPERIMENTAL

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

Drug: CFI-402257; Drug: Fulvestrant

Interventions

CFI-402257 DRUG

Cohort A; Cohort B; Cohort C

Fulvestrant DRUG

Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Patient who have had prior treatment with a TTK/MPS1 inhibitor

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CFI-402257; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Philippe Bedard, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 7, 2016
• Study Start: November 11, 2016
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)