Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2
The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in patients with HER2-tumor expression.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose and Pharmacokinetics of Oral TAK-165 Administered Once Daily to Subjects With Tumors Known to Express HER2.|
- Dose Limiting Toxicity [ Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit ] [ Designated as safety issue: No ]
- Maximum Tolerated Dose [ Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit ] [ Designated as safety issue: No ]
- Optimal Dosing for Phase II Studies. [ Time Frame: End of Study. ] [ Designated as safety issue: No ]
- Clinical Pharmacokinetic Profile of TAK-165 [ Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit ] [ Designated as safety issue: No ]
- Response Evaluation Criteria in Solid Tumors Documentation of Objective Tumor Response. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Study Completion Date:||September 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
|Experimental: TAK-165 QD||
Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.
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.
|United States, Arizona|
|Arizona Cancer Center|
|Scottsdale, Arizona, United States, 85258|
|United States, Texas|
|Brooke Army Medical Center/Drug Development Unit|
|San Antonio, Texas, United States, 78234|
|The Institute for Drug Development|
|San Antonio, Texas, United States, 78229|
|South Texas VA, Audie Murphy Division|
|San Antonio, Texas, United States, 78284|
|Study Director:||Medical Director||Takeda Global Research & Development Center, Inc.|