The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in patients with HER2-tumor expression.
The human epidermal growth factor receptor 2 (HER2) is a member of the Type 1 family of growth factor tyrosine kinases. HER2 forms hetero- and homo-dimers with other members of this family of tyrosine kinases. As a result of dimerization at the cell surface, intracellular signal transduction is initiated, resulting in cell proliferation. HER2 expression has been observed in a variety of human tumors including breast cancer, non-small cell lung cancer, prostate cancer, pancreatic cancer, renal cell cancer, and ovarian cancer. HER2 overexpression is associated with clinically more aggressive breast cancer, and is an independent predictor of poor prognosis in patients with breast cancer. TAK-165 is an active and selective inhibitor of tyrosine kinase activity of HER2 being developed for patients with lower levels of HER2 expression. This study will seek to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of TAK-165 administered to subjects with tumors known to express HER2. The total duration of the study will be at minimum 8 weeks, or 56 Days. Subjects without progressive disease after 8 weeks may continue to receive study drug, provided that they do not meet criteria for withdrawal.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.
Arizona Cancer Center
Scottsdale, Arizona, United States
The Institute for Drug Development
San Antonio, Texas, United States
Brooke Army Medical Center/Drug Development Unit
San Antonio, Texas, United States
South Texas VA, Audie Murphy Division
San Antonio, Texas, United States
Dose Limiting Toxicity
Time frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Maximum Tolerated Dose
Time frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Optimal Dosing for Phase II Studies.
Time frame: End of Study.
Clinical Pharmacokinetic Profile of TAK-165
Time frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Response Evaluation Criteria in Solid Tumors Documentation of Objective Tumor Response.
Time frame: Day 56
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