Clinical trial NCT00146172: Study Evaluating HKI-272 in Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Keywords: Tumors
Neratinib
HKI-272
Nerlynx
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: From first dose date to day 14
measure: Maximum Tolerated Dose (MTD)
timeFrame: From first dose date to day 14
Secondary outcomes:
measure: Number of Participants With Best Overall Response
timeFrame: From first dose date to progression or last tumor assessment, up to 39 weeks.
measure: Duration of Response
timeFrame: From start date of response to first PD, up to 39 weeks.
measure: Progression Free Survival
timeFrame: From first dose date to progression or death, up to 39 weeks.
measure: Objective Response Rate
timeFrame: From first dose date to progression/death or last assessment, up to 39 weeks
measure: Clinical Benefit Rate
timeFrame: From first dose date to progression/death or last assessment, up to 39 weeks.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation Taussig Cancer Center
state: Ohio
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References: