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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
HKI-272
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, United States
Dose Limiting Toxicity (DLT)
DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.
Time frame: From first dose date to day 14
Maximum Tolerated Dose (MTD)
If 2 or more, of 3 to 6 subjects, at a dose level had an neratinib-related dose limiting toxicity (DLT) by day 14 of continuous daily dose administration, dose escalation stopped and the prior dose level was considered the MTD.
Time frame: From first dose date to day 14
Number of Participants With Best Overall Response
Best Overall response by tumor type, evaluable population per Response Evaluation Criteria In Solid Tumors Criteria v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (LD) of target lesions in reference to baseline sum of LD of target lesions; Progressive Disease (PD), \>=20% increase in sum of LD of target lesions, taking as reference the smallest sum of recorded LD of target lesions since treatment started or appearance of 1 or more new lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD of target lesions since the treatment start. The best overall response was the best response recorded from start of treatment until PD/recurrence. In general, the subject's best response assignment depended on achievement of both measurement and confirmation criteria.
Time frame: From first dose date to progression or last tumor assessment, up to 39 weeks.
Duration of Response
Duration of response of responders (PR+) by Kaplan-Meier estimate
Time frame: From start date of response to first PD, up to 39 weeks.
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The Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Progression Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From first dose date to progression or death, up to 39 weeks.
Objective Response Rate
Patients with PR or higher responses, evaluable population
Time frame: From first dose date to progression/death or last assessment, up to 39 weeks
Clinical Benefit Rate
Patients with PR or higher responses or SD\>=24 weeks, evaluable population
Time frame: From first dose date to progression/death or last assessment, up to 39 weeks.