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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00034281

Public ClinicalTrials.gov record NCT00034281. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00034281
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Takeda
Industry
Enrollment
16 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2002
Primary completion
Aug 31, 2003
Completion
Aug 31, 2003
Last update posted
Feb 1, 2012

2002 – 2003

United States locations

U.S. sites
4
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Arizona Cancer Center Scottsdale Arizona 85258
The Institute for Drug Development San Antonio Texas 78229
Brooke Army Medical Center/Drug Development Unit San Antonio Texas 78234
South Texas VA, Audie Murphy Division San Antonio Texas 78284

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00034281, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 1, 2012 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00034281 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →