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TTK Inhibitor
CFI-402257 + Fulvestrant for Breast Cancer
Phase 1 & 2
Recruiting
Led By R Wesolowski
Research Sponsored by Treadwell Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part A Expansion: Breast cancer patients positive for estrogen receptor and/or progesterone receptor and negative for HER2, Must have previously received a CDK4/6 inhibitor, No limit on lines of endocrine therapy, Must have received no more than 1 line of cytotoxic chemotherapy, Have measurable disease as per RECIST 1.1 guidelines
Part A Escalation: Have histological or cytological proof of advanced cancer that has progressed on at least 1 prior line of systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial is testing an investigational drug to see if it is safe to use alone or with another drug to treat people with advanced solid tumors or advanced breast cancer.
Who is the study for?
This trial is for adults with advanced solid tumors or breast cancer that's positive for estrogen/progesterone receptors but negative for HER2. They must have tried certain therapies before, like a CDK4/6 inhibitor and possibly one line of endocrine therapy or chemotherapy. People can't join if they have brain cancer, serious heart conditions, are pregnant/nursing, had recent treatments/surgery, infections, blood clots or coagulopathy.Check my eligibility
What is being tested?
The study tests CFI-402257 alone in various advanced cancers and combined with Fulvestrant specifically in advanced breast cancer patients. It aims to determine the safety of these treatments and how well they work against these cancers.See study design
What are the potential side effects?
Potential side effects aren't listed here but generally could include typical reactions to cancer drugs such as nausea, fatigue, risk of infection due to lowered immunity; specific side effects would be detailed based on the drug's action.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have breast cancer that is positive for estrogen receptor and/or progesterone receptor, but negative for HER2. You have previously taken a CDK4/6 inhibitor and have received no more than one round of chemotherapy. You have measurable disease based on specific guidelines.
Select...
My advanced cancer has worsened despite previous treatment.
Select...
I have ER+/PR+ HER2- breast cancer, treated with CDK4/6 inhibitors, and limited prior therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the incidence of adverse events of CFI-402257 as a single agent and at the recommended phase 2 dose (RP2D)
To assess the incidence of adverse events of CFI-402257 in combination with fulvestrant and at the recommended phase 2 dose (RP2D)
Secondary outcome measures
Assessment of objective response rates
Assessment of objective response rates of the combination
Assessment of the pharmacokinetic profile of CFI-402257 in combination with fulvestrant through AUC
+2 moreSide effects data
From 2016 Phase 2 & 3 trial • 12 Patients • NCT0211680350%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
NASOPHARYNGITIS
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
INFLUENZA
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
HYPERTRIGLYCERIDAEMIA
10%
NAUSEA
10%
CONTUSION
10%
PLATELET COUNT DECREASED
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
LYMPHOCYTE COUNT DECREASED
10%
DYSPEPSIA
10%
DRY MOUTH
10%
PNEUMONIA
10%
HERPES ZOSTER
10%
ARTHRALGIA
10%
HYPOCALCAEMIA
10%
HYPERKALAEMIA
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B: Combination Escalation and ExpansionExperimental Treatment2 Interventions
Dose selection and expansion of CFI-402257 with Fulvestrant
Group II: Part A: Monotherapy Escalation and ExpansionExperimental Treatment1 Intervention
Dose selection and expansion of CFI-402257
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
FDA approved
Find a Location
Who is running the clinical trial?
Treadwell Therapeutics, IncLead Sponsor
3 Previous Clinical Trials
259 Total Patients Enrolled
R WesolowskiPrincipal InvestigatorThe Ohio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe uncontrolled high blood pressure, heart failure symptoms, chest pain, recent heart attack, constant irregular heartbeat, or a long QT interval.I have been treated with a TTK/MPS1 inhibitor before.I had radiotherapy less than 2 weeks ago.I haven't had chemotherapy or other cancer treatments in the last 4 weeks.I have previously been treated with fulvestrant or similar drugs.I have not had blood clotting issues or a history of them in the last 6 months.I have another active cancer besides my primary one.I have not had major surgery in the last 3 weeks.You have breast cancer that is positive for estrogen receptor and/or progesterone receptor, but negative for HER2. You have previously taken a CDK4/6 inhibitor and have received no more than one round of chemotherapy. You have measurable disease based on specific guidelines.I have not used growth factors within 14 days before starting CFI-402257 treatment.I currently have a serious infection.I do not have a bleeding disorder that prevents me from taking fulvestrant.I have a brain tumor or cancer that has spread to my brain.I am currently on a full dose of warfarin.My advanced cancer has worsened despite previous treatment.I have another active cancer besides ER+/HER2- advanced breast cancer.I have ER+/PR+ HER2- breast cancer, treated with CDK4/6 inhibitors, and limited prior therapy.I am not taking any strong medications that affect liver enzymes.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Monotherapy Escalation and Expansion
- Group 2: Part B: Combination Escalation and Expansion
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What aim is this inquiry seeking to achieve?
"According to the data provided by Treadwell Therapeutics, Inc., this 48-month assessment has a primary goal of quantifying adverse events associated with CFI-402257 as well as secondary objectives including measuring changes in variant allele function via circulating tumor deoxyribonucleic acid level comparison to baseline concentrations, evaluating the pharmacokinetic profile of CFI-402257 and fulvestrant when combined through area under concentration curves from time 0 to least measurable concentration tabulated per dose group ,and assessing objective response rates categorized within each tumour cohort."
Answered by AI
How many participants is the trial currently accommodating?
"This clinical trial requires 44 participants who meet the pre-defined eligibility criteria. Interested candidates may sign up at START - Mountain Region in West Valley City, Utah or The Ohio State University Comprehensive Cancer Centre in Columbus, Ohio."
Answered by AI
Is there currently an open enrolment period for this clinical trial?
"Indeed, the clinicaltrials.gov portal indicates that this research trial is actively seeking participants. Initial postings were made on May 27th 2022 and subsequently edited on July 26th of the same year. The study requires 44 volunteers across 3 separate sites."
Answered by AI
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