Safety And Tolerability Study Of TAK-165 In Subjects With Tumors Expressing HER2

Study Overview

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

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.

Breast Neoplasm
Pancreatic Neoplasm
Lung Neoplasm
Ovarian Neoplasm
Renal Neoplasm

DRUG: TAK-165

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-04-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-01-31
First Submitted that Met QC Criteria 2002-04-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-02-02
First Posted (ESTIMATED) 2002-04-25	Results First Posted N/A	Last Verified 2012-01

Study Plan

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

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.

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.

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

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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Medical Director, Takeda

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record