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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00146172 |
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Date of registration:
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02/09/2005 |
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Primary sponsor: |
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Public title:
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Study Evaluating HKI-272 in Tumors
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Scientific title:
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An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00146172 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Puma |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biotechnology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Her2/neu or Her1/EGFR positive cancer
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
- Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid
Tumors)
Exclusion Criteria:
- Prior treatment with anthracyclines with a cumulative dose of doxorubicin or
equivalent of greater than 300 mg/m2
- Patients with significant cardiac risk factors
- Active central nervous system metastasis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Intervention(s)
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Drug: neratinib
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Primary Outcome(s)
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Adverse events will be assessed on a continuous basis, physical exam, ECG, and ECOG performance status will be done at the beginning of every 1 month cycle. Laboratory evaluations will be performed approximately every 14 days.
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Secondary Outcome(s)
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Tumor assessment at screening and at the end of cycles 2, 4, and 6. Pharmacokinetics blood samples throughout study, including 8 hour PK day (sample every hour) on study day 14. Pharmacodynamic blood sample at screening and day 14.
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Secondary ID(s)
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3144A1-102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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