CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
HKI-272 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Pathologically confirmed solid tumor not curable with standard therapy (Part 1)
  • ✓Pathologically confirmed breast cancer (Part 2)
  • ✓HER2 positive tumor (Part 2)
  • ✓Prior treatment with Herceptin (Part 2)
Key exclusion· 13
  • ✕Active central nervous system metastases
  • ✕Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
  • ✕Bone or skin as the only site of disease
  • ✕Significant cardiac disease or dysfunction

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

Search/NCT00445458
NCT00445458Phase 2Completed
CompareCT.gov

A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer

Puma Biotechnology, Inc.·interventional·Posted Mar 9, 2007·Updated Jul 26, 2018

In Brief

A Phase 2 clinical trial evaluating HKI-272 and Paclitaxel for Advanced Breast Cancer and 2 related conditions. Completed, enrolled 110 participants across 32 sites in 9 countries.

Detailed Summary

The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Breast Cancer, Advanced Malignant Solid Tumors, Breast Neoplasms
CountriesBelgium, Canada, China, Hong Kong, India, Poland, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2007
Enrollment StartSep 11, 2007
Primary CompletionMay 1, 2011
Study CompletionFeb 7, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.3 years ago

Interventions

HKI-272drug

Paclitaxeldrug