Study Evaluating HKI-272 in Tumors

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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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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