Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Colorectal Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Pancreatic Neoplasms

Kidney Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Ovarian Cancer

Pancreatic Cancer

Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.

TAK-165

Medical Director

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.

Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2

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.

Takeda

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2	NCT00034281	Breast Neoplasm Pancreatic Neop... Lung Neoplasm Ovarian Neoplas... Renal Neoplasm	TAK-165	18 Years -	Takeda
Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2	NCT00034281	Breast Neoplasm Pancreatic Neop... Lung Neoplasm Ovarian Neoplas... Renal Neoplasm	TAK-165	18 Years -	Takeda

Spots Global Cancer Trial Database for gene, her2

Every month we try and update this database with for gene, her2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gene, her2

Every month we try and update this database with for gene, her2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gene, her2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.