Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2
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|ClinicalTrials.gov Identifier: NCT00034281|
Recruitment Status : Completed
First Posted : April 25, 2002
Last Update Posted : February 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Pancreatic Neoplasm Lung Neoplasm Ovarian Neoplasm Renal Neoplasm||Drug: TAK-165||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||September 2003|
|Experimental: TAK-165 QD||
Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034281
|United States, Arizona|
|Arizona Cancer Center|
|Scottsdale, Arizona, United States, 85258|
|United States, Texas|
|The Institute for Drug Development|
|San Antonio, Texas, United States, 78229|
|Brooke Army Medical Center/Drug Development Unit|
|San Antonio, Texas, United States, 78234|
|South Texas VA, Audie Murphy Division|
|San Antonio, Texas, United States, 78284|
|Study Director:||Medical Director||Takeda|