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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00034281
First received: April 24, 2002
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Neoplasm
Pancreatic Neoplasm
Lung Neoplasm
Ovarian Neoplasm
Renal Neoplasm
 Drug: TAK-165
 Phase 1

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: June 2002
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034281

Locations
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
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Director: Medical Director Takeda Global Research & Development Center, Inc.
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00034281     History of Changes
Other Study ID Numbers: 01-01-TL-165-001, U1111-1127-6123
Study First Received: April 24, 2002
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Gene, HER2
Clinical Trial, Phase I
Breast neoplasm
Pancreatic neoplasm
Ovarian neoplasm
 Colorectal neoplasm
Renal neoplasm
Prostate neoplasm
Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Kidney Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013