NCT02932280

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
5mo left

Started Oct 2016

Longer than P75 for phase_1

Geographic Reach
2 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2016Oct 2026

Study Start

First participant enrolled

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

10 years

First QC Date

October 12, 2016

Last Update Submit

December 3, 2025

Conditions

Central Nervous System TumorLymphomaLeukemiaSolid Tumor

Keywords

RecurrentRefractory DiseaseNeratinib16-878

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (1)

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.

Drug: Neratinib

Interventions

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).

Neratinib

Eligibility Criteria

Age3 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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)
  • ≥ 0.82
  • ≥ 0.66
  • ≥ 0.52
  • +10 more criteria

You may not qualify if:

  • 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:
  • days from allogeneic SCT
  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Phoenix Children'S Hospital

Phoenix, Arizona, 85016, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72206, United States

Location

Stanford University School of Medicine and Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Pennsylvania State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

University of Texas

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institue

Salt Lake City, Utah, 84113, United States

Location

Alberta Children'S Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaLeukemiaRecurrenceDisease

Interventions

neratinib

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tanya Trippett, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

US(8)CA(1)