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A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on 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 website dedicated 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 take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like 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 access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes 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. Human subjects often obtain the finest healthcare possible for their A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2 condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern 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 Breast Neoplasm Studies:
1. A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
2. Experimental Drug SS1(dsFv)-PE38 to Treat Cancer
3. A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)
4. Microarray Analysis for Human Genetic Disease
5. 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
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A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
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