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

January 31, 2012 updated by: Takeda

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Cancer Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • The Institute for Drug Development
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center/Drug Development Unit
      • San Antonio, Texas, United States, 78284
        • South Texas VA, Audie Murphy Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity
Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
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
Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Optimal Dosing for Phase II Studies.
Time Frame: End of Study.
End of Study.

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Pharmacokinetic Profile of TAK-165
Time Frame: Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
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
Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (ACTUAL)

September 1, 2003

Study Completion (ACTUAL)

September 1, 2003

Study Registration Dates

First Submitted

April 24, 2002

First Submitted That Met QC Criteria

April 24, 2002

First Posted (ESTIMATE)

April 25, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-01-TL-165-001
  • U1111-1127-6123 (REGISTRY: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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