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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034281
Recruitment Status : Completed
First Posted : April 25, 2002
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in patients with HER2-tumor expression.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Pancreatic Neoplasm Lung Neoplasm Ovarian Neoplasm Renal Neoplasm Drug: TAK-165 Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : June 2002
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Arm Intervention/treatment
Experimental: TAK-165 QD Drug: TAK-165
Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.

Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit ]
  2. Maximum Tolerated Dose [ Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit ]
  3. Optimal Dosing for Phase II Studies. [ Time Frame: End of Study. ]

Secondary Outcome Measures :
  1. Clinical Pharmacokinetic Profile of TAK-165 [ Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit ]
  2. Response Evaluation Criteria in Solid Tumors Documentation of Objective Tumor Response. [ Time Frame: Day 56 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have advanced or metastatic cancer which is refractory to standard therapy or subjects for whom there is no known effective therapy.
  • Have a histologically or cytologically proven diagnosis of a solid tumor known to express HER2.
  • Have a predicted life expectancy of greater than or equal to 12 weeks.
  • Have a Karnofsky Performance Status of greater than or equal to 60%
  • Have recovered from toxicities of prior chemotherapy, surgery, or radiotherapy.

Exclusion Criteria:

  • Be pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test result within 7 days of enrollment into the study. Male and female subjects of childbearing potential (including women who have been amenorrheic for less than 1 year) must use appropriate birth control during the entire duration of the study, or the subject must be surgically sterile.
  • Have symptomatic brain metastasis
  • Have received any other anti-cancer treatment or investigational drug/treatment within 28 days prior to study Day 1.
  • Have a history of another malignancy within the last 5 years.
  • Have inadequate organ function.
  • Have heart failure defined by an ejection fraction of less than or equal to 50% as measured by MUGA.
  • Have Class II, III or IV symptoms of heart failure as defined by the New York Heart Association, or uncontrolled arrhythmias, or recent history of myocardial infarction or angina pectoris.
  • Have a medical condition that may interfere with intake and/or absorption of the study drug (e.g., gastrectomy or resection of major portion of small intestine).
  • Have any other serious disease or condition present at screening or at study Day 1 that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00034281

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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
Sponsors and Collaborators
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Study Director: Medical Director Takeda
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Responsible Party: Takeda Identifier: NCT00034281    
Other Study ID Numbers: 01-01-TL-165-001
U1111-1127-6123 ( Registry Identifier: WHO )
First Posted: April 25, 2002    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012
Keywords provided by Takeda:
Gene, HER2
Clinical Trial, Phase I
Breast neoplasm
Pancreatic neoplasm
Ovarian neoplasm
Colorectal neoplasm
Renal neoplasm
Prostate neoplasm
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Kidney Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders
Urologic Neoplasms
Kidney Diseases
Urologic Diseases