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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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I've had chemotherapy for breast cancer, including treatments with anthracycline and taxane.
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I have advanced cancer with no other standard treatments available.
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I am fully active or can carry out light work.
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I can swallow pills.
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I am female.
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I am 18 years old or older.
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I am post-menopausal.
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I am 18 years old or older.
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I am female.
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My breast cancer is advanced, cannot be surgically removed, and cannot be cured.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I can swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing cohort
Secondary outcome measures
Area under the plasma concentration-time curve (AUC)
Average plasma concentration at steady state (Cavg)
Elimination half-life (T½)
+7 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%
PLATELET COUNT DECREASED
10%
CONTUSION
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
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
~3690
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,438 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with the use of CFI-402257 for humans?
"CFI-402257 has only been subject to preliminary testing, so its safety was attributed a score of 1."
Answered by AI
Is enrollment for this trial open to the public at this time?
"This trial is no longer in the process of finding patients. It was initiated on November 11th 2016 and had its final update on May 4th 2022. If you are considering other studies, there are 1,407 trials recruiting participants with breast cancer and 133 open clinical trials for CFI-402257 which still need volunteers."
Answered by AI
How many participants is the clinical trial currently accommodating?
"Unfortunately, this trial has stopped recruiting participants as of May 4th 2022. Initially posted on November 11th 2016, it is now replaced by 1407 clinical trials aimed at breast cancer and 133 studies related to CFI-402257 which are still actively looking for new patients."
Answered by AI
What prior studies have utilized CFI-402257 as a research tool?
"Initially observed at Lowell General Hospital in 2004, CIF-402257 has been tested extensively with 89 completed trials. Currently, 133 clinical studies are utilizing this medication, many of which are located near Ottawa, Ontario."
Answered by AI
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