|
Phase I Study of SU006668 in Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Phase I Study of SU006668 in Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase I Study of SU006668 in Patients With Advanced Solid Tumors Clinical research trials and Phase I Study of SU006668 in Patients With Advanced Solid Tumors medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Phase I Study of SU006668 in Patients With Advanced Solid Tumors. Phase I Study of SU006668 in Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Phase I Study of SU006668 in Patients With Advanced Solid Tumors clinical trial. Participants frequently obtain the most expert healthcare available for their Phase I Study of SU006668 in Patients With Advanced Solid Tumors condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase I Study of SU006668 in Patients With Advanced Solid Tumors  Phase I Study of SU006668 in Patients With Advanced Solid Tumors
Phase I Study of SU006668 in Patients With Advanced Solid Tumors
For Condition: Prostate Cancer,Colon Cancer,Rectal Cancer,Multiple Myeloma,Pancreatic Cancer,kidney tumor,Lung Cancer,Renal Cell Cancer,Gastric Cancer,Colorectal Cancer,Breast Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: Patient Abstract available in the near future.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of SU006668 in patients with advanced solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the objective response of patients treated with this drug. IV. Determine the toxic effects of this drug in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive oral SU006668 twice daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 6 to 12 patients receive escalating doses of SU006668 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Patients are followed at 30 days and then every 3 months thereafter. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of one of the following advanced malignancies: Breast; Colorectal; Non-small cell lung; Gastric; Pancreatic; Renal; Prostate; Myeloma - Failed standard therapy OR No effective standard therapy exists - Measurable or evaluable disease - No known CNS metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior anticancer biologic or immunotherapy and recovered; No prior SU006668; No other concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered; No concurrent chemotherapy - Endocrine therapy: At least 4 weeks since prior hormonal therapy; No concurrent hormonal therapy except for hormonal contraception or appetite stimulation - Radiotherapy: Recovered from prior radiotherapy - Surgery: At least 6 weeks since prior surgery; At least 6 months since prior coronary/peripheral artery bypass graft surgery; Prior major GI surgery allowed if no residual syptomatic manifestation of malabsorption; No prior organ transplantation - Other: At least 4 weeks since prior investigational agents; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Sex: Male or female - Menopausal status: Not specified - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; AST and ALT no greater than 3 times upper limit of normal - Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 40 mL/min - Cardiovascular: No myocardial infarction or severe/unstable angina within the past 6 months; No evidence of uncompensated coronary artery disease by electrocardiogram or physical exam - Other: No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix; No insulin-dependent diabetes mellitus; No non-insulin-dependent diabetes mellitus with clinical evidence of severe peripheral vascular disease or diabetic ulcers; No manifestation of malabsorption due to prior surgery, GI disease, or unknown reasons; No active inflammatory bowel disease; No known intolerance to any excipients in the study drug formulation; No other acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeeRosen, Study Chair, Jonsson Comprehensive Cancer Center
Additional Information:
Study ID Numbers: CDR0000068888; UCLA-0004061,NCI-G01-2010,SUGEN-SU6668.004
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024063
Other Breast Cancer Studies:
1. A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
2. ET-743 in Men with Advanced Prostate Cancer
3. PSA Vaccine or Nilutamide to Treat Advanced Prostate Cancer
4. Perifosine to Treat Prostate Cancer
5. Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
Related Studies:
Other Breast Cancer Clinical Trials
Other Clinical Trials
Other Clinical Trials
Phase I Study of SU006668 in Patients With Advanced Solid Tumors
|
|
|
|
|
|
|
|
