CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
neratinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00397046
NCT00397046Phase 1Completed
CompareCT.gov

An Ascending and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-272 Administered Orally to Japanese Subjects With Advanced Solid Tumors

Puma Biotechnology, Inc.·interventional·Posted Nov 8, 2006·Updated Sep 14, 2018

In Brief

A Phase 1 clinical trial evaluating neratinib for Tumors. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumors
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2006
Enrollment StartNov 1, 2006
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.7 years ago

Interventions

neratinibdrug

HKI-272