Solid TumorPhase 1/2NCT02932280
Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment
A Phase 1/2 study testing Neratinib in people with Solid Tumor and Central Nervous System Tumor, run by Memorial Sloan Kettering Cancer Center at 9 sites in 2 countries.
Trial summary
The purpose of this study is to test the safety of neratinib at different dose levels and to find out what effects, good and bad, it has on the patients and the cancer. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Solid Tumor, Central Nervous System Tumor, Lymphoma
- What is being tested?
- Neratinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Oct 2016to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis: Pathologic confirmation of solid tumor, including central nervous system tumor or lymphoma.
- Recurrent or Refractory Disease for which no further effective standard treatment is available.
- Patient must have failed at least one prior therapy.
- All patients must have evaluable disease as defined as:
- Solid tumors must have a lesion evaluable by RECIST criteria version 1.1;
- Central nervous system tumors will be evaluated by RANO criteria.
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- Available tissue to perform protein and genomic analysis
- Age:
- Phase 1: ≥ 3 and ≤ 21 years of age at time of enrollment
- Phase 2: ≥ 3 and ≤ 21 years of age at diagnosis
- Body Surface Area requirements varied by dose level:
- Dose Level BSA (m2)
- 1 ≥ 0.82
- ≥ 0.66
- ≥ 0.52
- ≥ 0.45
- Performance level:
- Lansky score ≥ 60% (patients < 16 years of age)
- Karnofsky score ≥ 60% (patients ≥ 16 years of age)
- Cardiac Function: Patients must have a shortening fraction ≥ 27% or left ventricular ejection fraction ≥ 50% measured by echocardiogram (ECHO) or measured by multiple-gated acquisition scans (MUGA).
- Negative β-human chorionic gonadotropin (hCG) pregnancy test for female patients of child-bearing potential ≤ 7 days before starting neratinib therapy.
- Female patients of reproductive potential must agree and commit to the use of a highly effective method of contraception, as determined to be acceptable by the investigator, from the time of informed consent until 28 days after the last dose of the investigational product. Male patients must agree and commit to use a barrier method of contraception while on treatment and for 3 months after the last dose of the investigational product.
- Written informed consent/assent prior to any study-specific procedures.
- Patient must be able to swallow tablet or have existing gastrostomy feeding tube to enable administration of tablet.
- Patients must have recovered from the acute toxic effects of all prior therapy to ≤ grade 1 before entering this study.
Who cannot join
- Prior treatment within the following timeframes:
- Systemic chemotherapy or biologic therapy ≤ 2 weeks or 5 half lives (t ½) of the agent used, whichever is shorter, prior to the start of neratinib
- Radiation therapy outside the central nervous system ≤ 14 days prior to neratinib
- Radiation to the central nervous system ≤ 12 weeks prior to initiation of neratinib
- Patients with previous allogeneic stem cell transplant (SCT) if they meet either of the following criteria:
- 60 days from allogeneic SCT
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- Active acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for GvHD
- Inadequate marrow function in Cohort 1:
- Absolute neutrophil count < 1.0 x 10^9 /L
- Platelets < 100 x 10^9 /L
- Hemoglobin < 8.0 g/dL (transfusion permitted at least 7 days prior to baseline)
- Total bilirubin > 1.5 X the upper limit of normal (ULN) for age
- AST (SGOT) and ALT (SGPT) > 3 X ULN (unless attributed to disease involvement)
- Serum creatinine > 1.5 X ULN for age or creatinine clearance ≤ 60mL/min/1.73m^2
- Symptomatic or unstable brain metastases. (Note: Asymptomatic patients with metastatic brain disease who have been on a stable dose of corticosteroids for treatment of brain metastases for at least 14 days (or decreasing dose of corticosteroid) are eligible to participate in the study.) Patients with primary central nervous system tumors are eligible.
- Clinically active cardiac disease, including prolonged QTc interval ≥ 481ms (i.e. ≥ grade 2)
- Pregnant or breast-feeding women
- Being actively treated for a concurrent malignancy with the exception of basal cell carcinoma or carcinoma in situ of the cervix.
- Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, unexplained fever > 38.5°C (101.3°F) or psychiatric illness/social situation that would limit compliance with study requirements.
- Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥ 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline).
- Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related disease
- Known history of hepatitis C or known active hepatitis B infection
- Known hypersensitivity to any component of the investigational product
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Pennsylvania State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
Arkansas Children's Hospital
Little Rock, Arkansas, 72206
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Stanford University School of Medicine and Stanford Cancer Institute
Palo Alto, California, 94304
Phoenix Children'S Hospital
Phoenix, Arizona, 85016
Huntsman Cancer Institue
Salt Lake City, Utah, 84113
University of Texas
San Antonio, Texas, 78229
About this study
Official title: A Phase I/II Study of Neratinib in Pediatric Patients With Relapsed or Refractory Solid Tumors
The purpose of this study is to test the safety of neratinib at different dose levels and to find out what effects, good and bad, it has on the patients and the cancer.
- Conditions
- Solid Tumor, Central Nervous System Tumor, Lymphoma, Leukemia
- Being tested
- Neratinib
- Keywords
- Recurrent, Refractory Disease, Neratinib, 16-878
- Medical subject headings
- Central Nervous System Neoplasms, Lymphoma, Leukemia, Recurrence, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeratinibDrug
Neratinib will be administered orally, or through existing gastrostomy feeding tube, once a day with food, preferably in the morning, continuously for 28-day cycles, with no rest between cycles. Dose will be scaled by body surface area (BSA).
| Study group | Role | What they receive |
|---|---|---|
| Neratinib | Experimental | 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. Receives: Drug: Neratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients who have experienced Dose Limiting Toxicity
NCI CTCAE Version 4.0.Definition of Hematologic Dose-Limiting Toxicity (solid tumor cohort only) Any hematologic toxicity as indicated: Febrile neutropenia defined as Grade 3 or 4 neutropenia with fever ≥ 38.5°C and /or infection requiring antibiotic or antifungal treatment Grade 4 neutropenia lasting > 7 days Grade 4 thrombocytopenia lasting > 7days Any drug-related adverse experience, regardless of grade, leading to a dose reduction of a study drug. Non-Hematologic Dose-Limiting Toxicities: Non-hematologic dose-limiting toxicity will be defined as any Grade 3, 4 or 5 nonhematologic toxicity with the specific exception of: Any grade diarrhea that occurs in the setting of poor compliance with supportive measures that last for < 48 hours Any grade dehydration related to diarrhea that occurs in the setting of inadequate compliance to supportive care measures that last for < 48 hours.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, M.D. Anderson Cancer Center, Stanford University, Arkansas Children's Hospital Research Institute, Alberta Children's Hospital, Phoenix Children's Hospital, University of Texas
- Responsible party
- Sponsor
- Investigators
- Tanya Trippett, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932280
- Sponsor's protocol ID
- 16-878
- Status last verified
- Nov 2026
- First submitted
- 12 Oct 2016
- Last updated
- 4 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Neratinib in Pediatric Patients With Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT02932280
- Acronym / sponsor ID
- 16-878
- Conditions
- Solid Tumor, Central Nervous System Tumor, Lymphoma, Leukemia
- Keywords
- Recurrent, Refractory Disease, Neratinib, 16-878
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, M.D. Anderson Cancer Center, Stanford University, Arkansas Children's Hospital Research Institute, Alberta Children's Hospital, Phoenix Children's Hospital, University of Texas
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety of neratinib at different dose levels and to find out what effects, good and bad, it has on the patients and the cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neratinib | Experimental | Drug: NeratinibThere 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. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- Diagnosis: Pathologic confirmation of solid tumor, including central nervous system tumor or lymphoma.
- Recurrent or Refractory Disease for which no further effective standard treatment is available.
- Patient must have failed at least one prior therapy.
- All patients must have evaluable disease as defined as:
- Available tissue to perform protein and genomic analysis
Key exclusion criteria (23 listed)
- Prior treatment within the following timeframes:
- Patients with previous allogeneic stem cell transplant (SCT) if they meet either of the following criteria:
- Inadequate marrow function in Cohort 1:
- Total bilirubin > 1.5 X the upper limit of normal (ULN) for age
- AST (SGOT) and ALT (SGPT) > 3 X ULN (unless attributed to disease involvement)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeratinibNeratinib will be administered orally, or through existing gastrostomy feeding tube, once a day with food, preferably in the morning, continuously for 28-day cycles, with no rest between cycles. Dose will be scaled by body surface area (BSA). | Drug | Neratinib |
Primary outcome
the number of patients who have experienced Dose Limiting Toxicity
Time frame: 1 year
NCI CTCAE Version 4.0.Definition of Hematologic Dose-Limiting Toxicity (solid tumor cohort only) Any hematologic toxicity as indicated: Febrile neutropenia defined as Grade 3 or 4 neutropenia with fever ≥ 38.5°C and /or infection requiring antibiotic or antifungal treatment Grade 4 neutropenia lasting > 7 days Grade 4 thrombocytopenia lasting > 7days Any drug-related adverse experience, regardless of grade, leading to a dose reduction of a study drug. Non-Hematologic Dose-Limiting Toxicities: Non-hematologic dose-limiting toxicity will be defined as any Grade 3, 4 or 5 nonhematologic toxicity with the specific exception of: Any grade diarrhea that occurs in the setting of poor compliance with supportive measures that last for < 48 hours Any grade dehydration related to diarrhea that occurs in the setting of inadequate compliance to supportive care measures that last for < 48 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Trippett, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neratinib in people with Solid Tumor and Central Nervous System Tumor, run by Memorial Sloan Kettering Cancer Center at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients who have experienced Dose Limiting Toxicity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.