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CFI-402257 + Fulvestrant for Solid Tumors
Phase 1
Waitlist Available
Led By Philippe Bedard, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort C: Must have an ECOG performance status of 0 or 1
Cohort B: Must have had prior lines of cytotoxic chemotherapy for breast cancer and prior treatment with anthracycline and taxane
Must not have
Patients with symptomatic congestive heart failure
Patients with active angina pectoris or recent myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug to see how safe and effective it is.
Who is the study for?
This trial is for adults with advanced solid tumors or breast cancer, where standard treatments no longer work. Participants need to have measurable disease, be in relatively good health (ECOG 0-1), and able to take oral meds. They should expect to live more than 3 months and agree to use effective birth control.
What is being tested?
The study tests CFI-402257's safety, tolerability, and how the body processes it. It's a phase 1 trial which means this drug is being given to humans for the first time. Patients will also receive Fulvestrant, an existing cancer treatment.
What are the potential side effects?
Since CFI-402257 is investigational, specific side effects are unknown but may include typical reactions seen with cancer drugs such as nausea, fatigue, blood count changes or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I've had chemotherapy for breast cancer, including treatments with anthracycline and taxane.
Select...
I have advanced cancer with no other standard treatments available.
Select...
I am fully active or can carry out light work.
Select...
I can swallow pills.
Select...
I am female.
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I am 18 years old or older.
Select...
I am post-menopausal.
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I am 18 years old or older.
Select...
I am female.
Select...
My breast cancer is advanced, cannot be surgically removed, and cannot be cured.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
I can swallow pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have symptoms of heart failure.
Select...
I have ongoing chest pain or had a recent heart attack.
Select...
I have a long-term irregular heartbeat or a prolonged QT interval.
Select...
I do not have any serious uncontrolled medical or mental health conditions.
Select...
I am not pregnant or nursing.
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I am currently on a full dose of warfarin.
Select...
I am currently taking certain medications.
Select...
I have been treated with a TTK/MPS1 inhibitor before.
Select...
My cancer has spread to my brain.
Select...
I am receiving or need treatment with growth factors.
Select...
I have a condition that makes it hard for me to take pills.
Select...
I have high blood pressure that isn't controlled by medication.
Select...
I do not have any serious or active infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850763%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Diarrhea
17%
Mucositis
17%
Headache
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Cough
11%
Anemia
11%
Upper respiratory infection
10%
Flu like symptoms
10%
Obesity
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Bone pain
7%
Dizziness
7%
Dyspepsia
7%
Pruritus
7%
Hot flashes
5%
Dysgeusia
5%
Pain
3%
Nail disorder
3%
Respiratory infection
3%
Abdominal pain
1%
Spinal cord compression
1%
Heart failure
1%
Bronchial infection
1%
Pleural effusion
1%
Ascites
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Osteonecrosis of jaw
1%
Urinary tract infection
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Renal failure
1%
Thromboembolic event
1%
Dislocation of hip
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment2 Interventions
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
Group II: Cohort BExperimental Treatment1 Intervention
CFI-402257 capsules will be taken orally, once a day, every day.
Group III: Cohort AExperimental Treatment1 Intervention
CFI-402257 capsules will be taken orally, once a day, every day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3520
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,192 Total Patients Enrolled
Philippe Bedard, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
76 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms of heart failure.I have ongoing chest pain or had a recent heart attack.I have a long-term irregular heartbeat or a prolonged QT interval.I am fully active or can carry out light work.I do not have any serious uncontrolled medical or mental health conditions.I understand the study's requirements and can give my consent.I am not pregnant or nursing.I have not had certain treatments recently.I understand the study's requirements and can give my consent.I've had chemotherapy for breast cancer, including treatments with anthracycline and taxane.I am currently on a full dose of warfarin.I am female.I had major surgery less than 3 weeks ago.I have advanced cancer with no other standard treatments available.I am fully active or can carry out light work.I can swallow pills.I am a woman who can have children and agree to use effective birth control.I understand the study's requirements and can give my consent.My breast cancer is ER/PR positive, HER2 negative, and cannot be cured with current treatments.I have been treated with aromatase inhibitor and CDK4/6 inhibitor.I am 18 years old or older.I am post-menopausal.I am a woman who can have children and agree to use effective birth control.I am currently taking certain medications.I am 18 years old or older.I can swallow pills.I have been treated with a TTK/MPS1 inhibitor before.My cancer has spread to my brain.I am receiving or need treatment with growth factors.I agree to use effective birth control methods.I am female.My breast cancer is advanced, cannot be surgically removed, and cannot be cured.I have a condition that makes it hard for me to take pills.I am 18 years old or older.I have high blood pressure that isn't controlled by medication.I am fully active or can carry out light work.I can swallow pills.I do not have any serious or active infections.I have been treated with or cannot take fulvestrant.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
- Group 3: Cohort C
Awards:
This trial has 1 awards, including:- 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.
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