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A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 Clinical research trials and A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2. A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2  A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
For Condition: Breast Neoplasm,Ovarian Neoplasm,Renal Neoplasm,Lung Neoplasm,Pancreatic Neoplasm
Status: No longer recruiting
Sponsor(s): Takeda Pharmaceuticals ,
Synopsis: This drug is being developed to treat specific cancer types, those with documented overexpression of a receptor known as HER2. The study is intended to determine a safe dose that is well tolerated by patients with cancer. Participants must have been diagnosed with a tumor with documented HER2 expression. All prior available treatments must have failed to treat the cancer.
Details: This is an open-label, dose-escalating study to determine the safety, tolerability and MTD of oral TAK-165 administered to subjects with tumor types known to express HER2, who are refractory to prior chemotherapy or for whom there is not an effective available therapy.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Subjects must: - have provided written informed consent; - have advanced or metastatic cancer which is refractory to standard therapy or for which there is no known effective therapy; - have HER2-expressing solid tumor; - have life expectancy of at least 12 weeks - have recovered from toxicities from prior chemotherapy, surgery or radiotherapy. Exclusion Criteria: Subjects will be excluded if: - pregnant or lactating - brain metastases are symptomatic - there is spinal cord compression - there is inadequate bone marrow reserve - there is inadequate liver function - there is inadequate renal function
Total Enrollment:
Location and Contact Information:
Brooke Army Medical Center/Drug Development Unit
San Antonio, Texas, 78234
United States
South Texas VA, Audie Murphy Division
San Antonio, Texas, 78284
United States
The Institute for Drug Development
San Antonio, Texas, 78229
United States
Arizona Cancer Center
Scottsdale, Arizona, 85258
United States
Additional Information:
Study ID Numbers: 01-01-TL-165-001;
Study Start Date: April 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034281
Other Ovarian Neoplasm Studies:
1. Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial
2. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
3. A Prospective Study to Evaluate Potential Factors Affecting Weight Among Breast Cancer Patients Receiving Adjuvant Chemotherapy
4. Allogeneic (Donor) Bone Marrow Transplant to Treat Breast Cancer
5. Effects of Raloxifene on the Uterus and Ovaries of Premenopausal Patients
Related Studies:
Other Ovarian Neoplasm Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
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