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Study Evaluating HKI-272 Administered to Healthy Subjects

21:10 EDT 18th June 2013 | BioPortfolio

Summary

Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Healthy

Intervention

neratinib

Location

Tacoma
Washington
United States
98418

Status

Completed

Source

Puma Biotechnology, Inc.

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Clinical Trials [ 15 Associated Clinical Trials listed on BioPortfolio]

A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

The purpose of the study is to demonstrate the bioequivalence of the proposed commercial neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet formulation (40...

Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib

This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.

A Study of Neratinib (HKI-272) + Capecitabine in Japanese With Solid Tumor

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

Study Evaluating the Effects of Neratinib in Women With Early Stage Breast Cancer

The purpose of this study is to investigate whether neratinib can reduce the risk of previously diagnosed HER-2 positive breast cancer from returning after treatment with trastuzumab.

Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects and Subjects With Chronic Liver Disease

The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.

PubMed Articles [ 4 Associated PubMed Articles listed on BioPortfolio]

A Single-Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study to Assess the Effects of Neratinib (HKI-272) on Cardiac Repolarization in Healthy Adult Subjects.

PURPOSE: Neratinib is an orally administered, small-molecule, irreversible pan-ErbB inhibitor in development for the treatment of ErbB2-positive breast cancer. This study assessed the effects of thera...

Reversible Covalent Binding of Neratinib to Human Serum Albumin In Vitro.

Neratinib (HKI-272), an irreversible inhibitor of Her 2 tyrosine kinase, is currently in development as an alternative for first and second line therapy in metastatic breast cancer patients who overex...

The Adjuvant Treatment of HER2-Positive Breast Cancer.

OPINION STATEMENT: About 15-20% of patients with early stage breast cancer present with tumors that have overexpression or amplification of the human epidermal growth factor receptor 2 (HER2) gene. Be...

An update on molecularly targeted therapies in second- and third-line treatment in non-small cell lung cancer: focus on EGFR inhibitors and anti-angiogenic agents.

Docetaxel, pemetrexed and epidermal growth factor receptor tyrosine kinase inhibitors (gefitinib and erlotinib) are recommended second-line therapy for advanced non-small cell lung cancer (NSCLC) pati...

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