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

Completed · Phase 1

Conditions studied: Breast Neoplasm, Pancreatic Neoplasm, Lung Neoplasm, Ovarian Neoplasm, Renal Neoplasm

In brief

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

Key facts

Study ID

NCT00034281

Run by

Takeda

People needed

16

Starts

2002-06-01

Expected to finish

2003-09-01

Last updated by the study team

2012-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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