Study Evaluating HKI-272 in Tumors

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00146172

3144A1-102

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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73 participants in 8 patient groups

Neratinib 40 mg

Experimental group

Treatment:

Drug: neratinib

Neratinib 80 mg

Experimental group

Treatment:

Drug: neratinib

Neratinib 120 mg

Experimental group

Treatment:

Drug: neratinib

Neratinib 180 mg

Experimental group

Treatment:

Drug: neratinib

Neratinib 240 mg

Experimental group

Treatment:

Drug: neratinib

Neratinib 320 mg

Experimental group

Treatment:

Drug: neratinib

Neratinib 400 mg

Experimental group

Treatment:

Drug: neratinib

Neratinib 320 mg MTD

Experimental group

Treatment:

Drug: neratinib