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Tyrosine Kinase Inhibitor
Neratinib for Resistant or Recurrent Cancer
Phase 1 & 2
Waitlist Available
Led By Tanya Trippett, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be able to swallow tablet or have existing gastrostomy feeding tube to enable administration of tablet
Age: Phase 1 - ≥ 3 and ≤ 21 years of age at time of enrollment, Phase 2 - ≥ 3 and ≤ 21 years of age at diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing the safety of neratinib, and its effects on patients and cancer.
Who is the study for?
This trial is for children and young adults aged 3 to 21 with recurrent or resistant cancers like brain tumors, lymphoma, leukemia, and solid tumors. They must have tried at least one treatment before, be able to swallow tablets or use a feeding tube, and have no severe heart issues. Females of childbearing age and males must agree to effective contraception.Check my eligibility
What is being tested?
The study is testing the safety of different doses of Neratinib on young patients with cancer that has returned or didn't respond to previous treatments. It aims to discover both positive and negative effects this drug may have on their condition.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Neratinib can include diarrhea, nausea, abdominal pain, fatigue, rash. Side effects vary by individual; some may experience more severe reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills or have a feeding tube.
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I am between 3 and 21 years old.
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I have been diagnosed with a solid tumor or lymphoma.
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My condition has returned or hasn't responded to treatment, and no standard treatments are effective.
Select...
I have tried at least one treatment that didn't work for me.
Select...
I have tissue available for protein and genomic tests.
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I agree to use barrier contraception during and for 3 months after treatment.
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My heart's pumping ability is within a healthy range.
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I am mostly active and can do some activities or work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
the number of patients who have experienced Dose Limiting Toxicity
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
1Treatment groups
Experimental Treatment
Group I: NeratinibExperimental Treatment1 Intervention
There are 2 parts to this study: a Phase I part and a Phase II part. The Phase I portion is known as the dose escalation phase where neratinib will be tested in groups of 3-6 patients to establish the maximum tolerated dose (MTD). The phase II portion will determine whether the MTD shows a response to the tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
2014
Completed Phase 2
~1970
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,868 Total Patients Enrolled
155 Trials studying Lymphoma
8,725 Patients Enrolled for Lymphoma
Milton S. Hershey Medical CenterOTHER
495 Previous Clinical Trials
2,798,860 Total Patients Enrolled
6 Trials studying Lymphoma
59 Patients Enrolled for Lymphoma
M.D. Anderson Cancer CenterOTHER
2,975 Previous Clinical Trials
1,789,495 Total Patients Enrolled
253 Trials studying Lymphoma
32,528 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills or have a feeding tube.I am not being treated for another cancer, except for skin cancer or early-stage cervical cancer.I have not had chemotherapy, biologic therapy, or radiation recently.I had a stem cell transplant from a donor and meet specific criteria.My blood cell counts are too low.I have brain metastases but am stable on my current corticosteroid dose without symptoms.I have a heart condition with a long QT interval.Women who could become pregnant must have a negative pregnancy test within 7 days before starting neratinib therapy.I do not have any uncontrolled illness or social situations that would stop me from following the study's requirements.I have a long-term stomach problem that causes severe diarrhea.You are allergic to any part of the study drug.I have been diagnosed with a solid tumor or lymphoma.My condition has returned or hasn't responded to treatment, and no standard treatments are effective.I have tried at least one treatment that didn't work for me.I have tissue available for protein and genomic tests.I agree to use barrier contraception during and for 3 months after treatment.My heart's pumping ability is within a healthy range.I have been diagnosed with HIV/AIDS.I have a history of hepatitis C or currently have active hepatitis B.I am between 3 and 21 years old.My body size fits the required range for the medication dose.I have recovered from side effects of my previous treatments.You must have a measurable tumor according to specific guidelines.I am mostly active and can do some activities or work.
Research Study Groups:
This trial has the following groups:- Group 1: Neratinib
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.
Does this research permit the participation of individuals aged sixty and older?
"This clinical trial's eligibility criteria implies that it is only available to youth between 3 and 21 years of age. 899 trials are made accessible for patients below 18 while 4713 studies can be joined by those over 65."
Answered by AI
Are there any additional experiments that have been conducted involving Neratinib?
"City of Hope initiated the exploration of neratinib in 2010 and has since concluded 32 trials. Currently, there are 20 active studies taking place primarily around Palo Alto, California."
Answered by AI
What is the participating population of this trial?
"Affirmative. The publicly available information on clinicaltrials.gov reveals that this investigation, initially posted on October 1st 2016, is presently recruiting individuals to participate. This endeavor necessitates the recruitment of 47 people from 9 different medical facilities."
Answered by AI
Are there many venues where this clinical experiment is being conducted in North America?
"At this time, 9 medical centres are participating in the study. These sites can be found in Palo Alto, Hershey and New york as well as 6 other locations. To minimize travel burdens for those who join us, we recommend selecting the site closest to you."
Answered by AI
Is enrollment still open for this clinical experiment?
"Per the clinicaltrials.gov page, this investigation is still recruiting participants since its inception on October 1st 2016 and subsequent update on March 21st 2022."
Answered by AI
How can I join the scientific research involving this clinical trial?
"For consideration in this medical trial, participants must be 3-21 years old and have been diagnosed with lymphoma. So far, 47 individuals have met the entry requirements of this research study."
Answered by AI
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