Your session is about to expire
← Back to Search
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
Abnormal HER-family and c-Met signaling activity based on CELsignia MP Test results (for phase II patients only)
Participants must have adequate organ function including the following laboratory values at the screening visit. Screening must occur within 28 days prior to the first dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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...
My test shows abnormal HER-family and c-Met activity.
Select...
My organs are functioning well according to recent tests.
Select...
My breast cancer cannot be cured with current treatments and I've tried 1-6 treatments for it.
Select...
I am 18 years old or older.
Select...
My cancer can be any type for Phase 1b, but must be HER2-negative for Phase 2.
Select...
I am fully active or can carry out light work.
Select...
I have a tumor that can be measured and biopsied.
Select...
My breast cancer has spread or is inflammatory, as confirmed by a doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine maximum tolerated dose for use in the Phase II portion of the trial
To determine overall response rate (ORR: CR+PR)
Side effects data
From 2022 Phase 2 trial • 11 Patients • NCT03094052100%
Diarrhea
100%
Constipation
82%
Nausea
45%
Fatigue
45%
Abdominal distension
36%
Headache
36%
Dizziness
27%
Hot flashes
27%
Pruritus
27%
Dyspnea
27%
Weight loss
27%
Vomiting
27%
Anorexia
18%
Dysgeusia
18%
Alanine aminotransferase increased
18%
Aspartate aminotransferase increased
18%
Fever
18%
Gastrointestinal disorders - Other, specify
18%
Abdominal pain
18%
Bloating
18%
Sinus bradycardia
18%
Skin and subcutaneous tissue disorders - Other, specify
9%
Anxiety
9%
Cholecystitis
9%
Mucositis oral
9%
Paresthesia
9%
Rash maculo-papular
9%
Upper respiratory infection
9%
Fracture
9%
Back pain
9%
Joint range of motion decreased
9%
Vaginal dryness
9%
Lymphedema
9%
Anal hemorrhage
9%
Muscle weakness upper limb
9%
Musculoskeletal and connective tissue disorder - Other, specify
9%
Vaginal hemorrhage
9%
Chills
9%
Vaginal discharge
9%
Gastroesophageal reflux disease
9%
Creatinine increased
9%
Bruising
9%
Vaginal infection
9%
Arthralgia
9%
Pain
9%
Urinary tract pain
9%
Wheezing
9%
Ejection fraction decreased
9%
Peripheral sensory neuropathy
9%
Insomnia
9%
Flatulence
9%
Flu like symptoms
9%
Rash acneiform
9%
Oral dysesthesia
9%
Stomach pain
9%
General disorders and administration site conditions - Other, specify
9%
Infections and infestations - Other, specify
9%
Fall
9%
Neck pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)
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
2,967 Previous Clinical Trials
1,804,746 Total Patients Enrolled
147 Trials studying Breast Cancer
63,230 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:- 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 5 Other Conditions - This treatment demonstrated efficacy for 5 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 is the participant count for this experiment?
"Correct. According to the information provided on clinicaltrials.gov, this particular medical trial launched in August 18th 2022 and is still recruiting participants. Specifically, 56 patients need to be recruited from a single site."
Answered by AI
Are enrollments being taken for this clinical experiment at present?
"According to the clinicaltrials.gov website, this medical study is in its active recruitment phase, having been first posted on August 18th 2022 and updated most recently on October 26th 2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger