Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment

  • End date
    Oct 26, 2024
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 26 August 2023
ejection fraction
human chorionic gonadotropin
solid tumour
solid tumor
cns tumor


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.

Condition Solid Tumor, Central Nervous System Tumor, Lymphoma, Leukemia
Treatment Neratinib
Clinical Study IdentifierNCT02932280
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on26 August 2023


Yes No Not Sure

Inclusion Criteria

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
Available tissue to perform protein and genomic analysis
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)
≥ 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
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
multiple-gated acquisition scans (MUGA)
Written informed consent/assent prior to any study-specific procedures
Negative β-human chorionic gonadotropin (hCG) pregnancy test for female patients of child-bearing potential ≤ 7 days before starting neratinib therapy
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

Exclusion Criteria

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
days from allogeneic SCT
Patients with previous allogeneic stem cell transplant (SCT) if they meet either of
Active acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for GvHD
the following criteria
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)
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
Pregnant or breast-feeding women
Serum creatinine > 1.5 X ULN for age or creatinine clearance ≤ 60mL/min/1.73m^2
Being actively treated for a concurrent malignancy with the exception of basal cell carcinoma or carcinoma in situ of the cervix
Clinically active cardiac disease, including prolonged QTc interval ≥ 481ms (i.e. ≥ grade 2)
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
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
Known hypersensitivity to any component of the investigational product
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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