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

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

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.