CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 73 enrolled
Drug / intervention
neratinibdrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓HER2/neu or HER1/EGFR-positive cancer
  • ✓ECOG performance status 0–2
  • ✓Measurable disease by RECIST criteria
Key exclusion· 3
  • ✕Prior anthracyclines with cumulative doxorubicin dose >300 mg/m²
  • ✕Significant cardiac risk factors
  • ✕Active central nervous system metastasis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00146172
NCT00146172Phase 1Completed
CompareCT.gov

An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors

Puma Biotechnology, Inc.·interventional·Posted Sep 5, 2005·Updated Sep 17, 2018

In Brief

A Phase 1 clinical trial evaluating neratinib for Breast Neoplasms. Completed, enrolled 73 participants across 5 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272. In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartNov 1, 2003
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.8 years ago

Interventions

neratinibdrug

HKI-272