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Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer Clinical research trials and Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer. Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer  Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer
Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Millennium Pharmaceuticals ,
Synopsis: This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.
Details: This is a Phase 1 open-label dose-escalating trial designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics of a single dose of MLN2704 in subjects with metastatic androgen-independent prostate cancer.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: Inclusion Criteria Each subject must meet the following inclusion criteria to be eligible for enrollment in the study: - Histologic diagnosis (recent or remote) of prostate adenocarcinoma - Progressive prostate cancer on physical exam, imaging studies and/or rising PSA, as defined by the presence of one or more of the following: *Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI) *Progressive bone metastasis (presence of new lesion(s) on a bone scan) *Progressive PSA levels despite castrate levels of testosterone *Patients who have received an anti-androgen must have shown progression of disease off of the anti-androgen prior to enrollment - Failed hormonal therapy (including anti-androgen withdrawal therapy, as appropriate) - LHRH (Luteinizing Hormone–Releasing Hormone)analog therapy: - If subject is being treated with LHRH analog therapy at the time of screening the therapy must be maintained for the duration of the trial. - If subject discontinued LHRH therapy prior to screening, the therapy must be discontinued 10 weeks prior to enrollment for 1 month depot preparations, 24 weeks for 3 month depot preparations, and 32 weeks for 4 month depot preparations. - Agree to use an effective method of barrier contraception. Effective method of barrier contraception includes a condom with spermicidal jelly, a diaphragm with spermicidal jelly, or abstinence. Exclusion Criteria Subjects meeting any of the following exclusion criteria are not to be enrolled in the study: - Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of enrollment - Use of PC-SPES (herbal supplement) within 4 weeks of enrollment - Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of enrollment - Use of anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) within 6 weeks of enrollment - Prior monoclonal antibody administration, including Prostacint® - Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC) - History of CNS metastasis, including epidural disease - History of seizure disorder requiring active treatment and/or stroke - History of HIV infection - Platelet count 100,000/mm3 - Absolute neutrophil count (ANC) 1,500/mm3 - Hematocrit 30 percent - Abnormal coagulation profile (PT, and/or INR, PTT) - Creatinine clearance <60 mL/min or Serum creatinine >2.0 mg/dL - AST or ALT >1.5 X ULN - Bilirubin (total) >ULN - Serum calcium 12.5 mg/dL - Active serious infection not controlled by antibiotics - Active angina pectoris or NY Heart Association Class III-IV heart disease - Karnofsky Performance Status <60 - Life expectancy <6 months - Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems that might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
Total Enrollment: 29
Location and Contact Information:
The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Denise Collins 800-589-9005
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Denise Collins 800-589-9005
Additional Information:
Study ID Numbers: M59102-042;
Study Start Date: November 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052000
Other Prostate Cancer Studies:
1. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
2. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
3. A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
4. Treatment with Zometa in patients with breast cancer, multiple myeloma, and prostate cancer with cancer related bone lesions
5. ET-743 in Men with Advanced Prostate Cancer
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Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer
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