NCT02932280

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

A Phase I/II Study of Neratinib in Pediatric Patients With Relapsed or Refractory Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Central Nervous System Tumor
• Lymphoma
• Leukemia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2016-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2016-10-13
• Last updated: 2025-12-05

Locations

9 sites across 2 countries: United States, Canada