Study Evaluating HKI-272 in Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

NCT00300781

Breast Neoplasms Neoplasms

COMPLETED PHASE2

A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

NCT00398567

Advanced Breast Cancer

COMPLETED PHASE1/PHASE2

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

NCT00741260

Breast Cancer

COMPLETED PHASE1/PHASE2

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

NCT00445458

Advanced Breast Cancer Advanced Malignant Solid Tumors Breast Neoplasms

COMPLETED PHASE1/PHASE2

Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

NCT00706030

Breast Cancer Advanced Malignant Solid Tumors

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

This trial was an open-label, phase 1, ascending single and multiple oral dose study of HKI-272 administered to subjects with erbB-2- or erbB-1-positive tumors. Each subject participated in only 1 dose group and received a single dose of test article, followed by a 1-week observation period, and then received the test article administered once daily by mouth for up to 6 months (6 cycles). Daily dose administration could continue beyond 6 cycles at the same dose level if HKI-272 was well tolerated and there was no evidence of progressive disease.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neratinib 40 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Neratinib 80 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Neratinib 120 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Neratinib 180 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Neratinib 240 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Neratinib 320 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Neratinib 400 mg

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Neratinib 320 mg MTD

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

neratinib

HKI-272

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Her2/neu or Her1/EGFR positive cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria

* Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m\^2
* Patients with significant cardiac risk factors
* Active central nervous system metastasis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No