CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
Neratinib +1 moredrug
Likely dose
Neratinib 240 mgfrom 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/NCT01128842
NCT01128842Phase 1Completed

A Phase 1, Open-Label Study Of Neratinib (HKI-272) In Combination With Capecitabine In Japanese Subject With Solid Tumors

Puma Biotechnology, Inc.·interventional·Posted May 24, 2010·Updated Dec 19, 2018

In Brief

A Phase 1 clinical trial evaluating Neratinib and Capecitabine for Advanced Malignant Solid Tumors. Completed, enrolled 7 participants across 2 sites.

Detailed Summary

This is an open-label, phase 1 study of a single cohort of neratinib (HKI-272) in combination with capecitabine.

Study Details

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

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2010
Enrollment StartApr 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.1 years ago

Interventions

Neratinibdrug

240 mg once daily by mouth.

Capecitabinedrug

1500 mg/m\^2 twice daily by mouth.