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Tyrosine Kinase Inhibitor
Neratinib + Capmatinib for Breast Cancer
Phase 1 & 2
Recruiting
Led By Rachel Layman
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years
ECOG performance status 0-1
Must not have
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
Severe infections within 4 weeks prior to study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is to study if the drugs capmatinib and neritinib can help control metastatic or locally advanced breast cancer, as well as to find the highest tolerable dose of the combination therapy.
Who is the study for?
This trial is for adults with metastatic or inflammatory breast cancer who have not responded to standard treatments. They must be in good physical condition, have a heart function within normal range, and show abnormal HER-family and c-Met signaling activity. Pregnant women, those with recent major surgeries or severe infections, uncontrolled heart conditions, or inability to swallow medications are excluded.
What is being tested?
Researchers are testing the combination of two drugs: Neratinib and Capmatinib. The goal is to find the highest dose patients can tolerate without serious side effects and see if this drug combo helps control advanced breast cancer better than current treatments.
What are the potential side effects?
Potential side effects may include diarrhea, liver issues, rash, nausea, vomiting; changes in heartbeat or blood pressure could occur due to cardiac risks associated with these drugs. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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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My breast cancer has spread or is inflammatory, as confirmed by a doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart failure.
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I haven't had severe infections or been hospitalized for them in the last 4 weeks.
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I haven't had major surgery in the last 28 days and don't expect to need one during the study.
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I am not on medications that can't be stopped a week before and during the study.
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I have not taken any antibiotics by mouth or IV in the last 5 days.
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My heart rhythm problem is not controlled by medication.
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My heart rhythm problem isn't controlled by medication.
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I haven't needed strong treatments for flare-ups in the last year.
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I cannot take pills due to stomach or bowel problems.
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I have or my family has a history of sudden death or Long QT syndrome.
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I am not on any seizure medication that affects enzyme levels, or I can stop it before starting the study treatment.
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I have irregular heartbeats from the lower chambers of my heart.
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I do not have an active hepatitis B or C infection.
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I have or had lung conditions affecting my daily activities or needed treatment.
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I have serious heart conditions that are not under control.
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I do not have significant liver disease like hepatitis or cirrhosis.
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 2022 Phase 2 trial • 11 Patients • NCT03094052100%
Diarrhea
100%
Constipation
82%
Nausea
45%
Abdominal distension
45%
Fatigue
36%
Dizziness
36%
Headache
27%
Dyspnea
27%
Hot flashes
27%
Anorexia
27%
Vomiting
27%
Pruritus
27%
Weight loss
18%
Skin and subcutaneous tissue disorders - Other, specify
18%
Dysgeusia
18%
Bloating
18%
Fever
18%
Abdominal pain
18%
Gastrointestinal disorders - Other, specify
18%
Aspartate aminotransferase increased
18%
Alanine aminotransferase increased
18%
Sinus bradycardia
9%
Muscle weakness upper limb
9%
Neck pain
9%
Rash acneiform
9%
Lymphedema
9%
Rash maculo-papular
9%
Vaginal dryness
9%
Back pain
9%
Anal hemorrhage
9%
Paresthesia
9%
Gastroesophageal reflux disease
9%
Pain
9%
Infections and infestations - Other, specify
9%
Urinary tract pain
9%
Flu like symptoms
9%
Fracture
9%
Flatulence
9%
Mucositis oral
9%
Chills
9%
General disorders and administration site conditions - Other, specify
9%
Ejection fraction decreased
9%
Oral dysesthesia
9%
Peripheral sensory neuropathy
9%
Creatinine increased
9%
Upper respiratory infection
9%
Vaginal infection
9%
Stomach pain
9%
Bruising
9%
Fall
9%
Joint range of motion decreased
9%
Musculoskeletal and connective tissue disorder - Other, specify
9%
Arthralgia
9%
Vaginal discharge
9%
Vaginal hemorrhage
9%
Wheezing
9%
Anxiety
9%
Insomnia
9%
Cholecystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2 (dose expansion)Experimental Treatment2 Interventions
This portion of the study will enroll a maximum of 29 patients
Group II: Part 1b (dose escalation)Experimental Treatment2 Interventions
This portion of the study will enroll a maximum of 27 patients in the dose-finding trial including the possibility of adding up to 6 additional ER+ patients in a safety assessment of aromatic inhibitor treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
FDA approved
Capmatinib
FDA approved
Find a Location
Who is running the clinical trial?
Celcuity IncIndustry Sponsor
7 Previous Clinical Trials
960 Total Patients Enrolled
2 Trials studying Breast Cancer
842 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,599 Total Patients Enrolled
146 Trials studying Breast Cancer
63,026 Patients Enrolled for Breast Cancer
Celcuity, Inc.Industry Sponsor
6 Previous Clinical Trials
906 Total Patients Enrolled
2 Trials studying Breast Cancer
842 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart failure.I haven't had severe infections or been hospitalized for them in the last 4 weeks.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I am using effective birth control and can become pregnant.My side effects from cancer treatment are mild, except for hair loss, skin changes, or certain symptoms that were present at the start.I haven't had major surgery in the last 4 weeks or brain surgery in the last 2 weeks, or I've recovered from any side effects.My test shows abnormal HER-family and c-Met activity.Your heart's pumping ability (measured by MUGA scan or echocardiogram) is at least 50%.I am not on medications that can't be stopped a week before and during the study.My organs are functioning well according to recent tests.I am a man who will use a condom during the study and for 3 months after, and I won't father a child or donate sperm in this time.My breast cancer cannot be cured with current treatments and I've tried 1-6 treatments for it.I have not taken any antibiotics by mouth or IV in the last 5 days.My heart rhythm problem is not controlled by medication.I have had a heart attack in the last 6 months.I am 18 years old or older.Your heart's QT interval is longer than 470 milliseconds on the screening test.My heart rhythm problem isn't controlled by medication.My blood pressure is not controlled, even with medication.I haven't needed strong treatments for flare-ups in the last year.I haven't had cancer treatment in the last 2 weeks, except for brain metastasis treatment.I cannot take pills due to stomach or bowel problems.You have HIV and either a low CD4+ count or have recently had serious infections related to AIDS.My cancer can be any type for Phase 1b, but must be HER2-negative for Phase 2.I haven't had signs of infection in the last 2 weeks.I have or my family has a history of sudden death or Long QT syndrome.I have not had unstable chest pain in the last 6 months.I am not on any seizure medication that affects enzyme levels, or I can stop it before starting the study treatment.I have irregular heartbeats from the lower chambers of my heart.I am fully active or can carry out light work.I do not have an active hepatitis B or C infection.I have or had lung conditions affecting my daily activities or needed treatment.I have serious heart conditions that are not under control.I have a tumor that can be measured and biopsied.My breast cancer has spread or is inflammatory, as confirmed by a doctor.I do not have significant liver disease like hepatitis or cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1b (dose escalation)
- Group 2: Part 2 (dose expansion)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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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