Purpose

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.

Category

IRB Number
20170390HU
NCT Number
NCT02932280
Open to Enrollment
Yes
Sponsor
Memorial Sloan Kettering Cancer Center -



Study Contact

Local Recruitment Point of Contact
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Principal Investigator
Anne-Marie Langevin

Regulatory Point of Contact
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu



Eligibility

Eligible Ages
Between 3 Years and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 1/Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Solid Tumor
    2. Central Nervous System Tumor
    3. Lymphoma
    4. Leukemia

      5. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Neratinib

      		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.
    5. Drug: Neratinib

      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).

      6.