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A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer Clinical research trials and A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer. A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer clinical trial. Human subjects often get the best healthcare available for their A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer  A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
For Condition: Prostatic Neoplasms
Status: Recruiting
Sponsor(s): Millennium Pharmaceuticals ,
Synopsis: The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times 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, broken down and eliminated by the body.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria: 1. Histologic or cytologic diagnosis (recent or remote) of prostate adenocarcinoma 2. Radiographic evidence (recent or remote) of metastatic prostate adenocarcinoma 3. 18 years of age or older 4. Progressive prostate cancer as defined by the presence of one or more of the following despite castrate levels of testosterone (testosterone <50 ng/dL): • 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 (as defined in Section 3.6.1) 5. Subjects who have received an anti-androgen must have shown progression of disease following discontinuation of the anti-androgen 6. Subjects must remain on LHRH analog therapy for the duration of the trial unless surgically castrate 7. Agree to use an effective barrier method of contraception. Exclusion criteria: 1. Testosterone >50 ng/dL 2. Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of dosing 3. Use of PC-SPES within 4 weeks of dosing 4. Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of dosing 5. Use of anti-androgen therapy (eg, flutamide, bicalutamide, nilutamide) within 6 weeks of dosing 6. Prior monoclonal antibody administration, including Prostascint® 7. Peripheral neuropathy of Grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) 8. History of CNS metastasis, including incompletely treated epidural disease 9. History of Hepatitis B or C 10. History of seizure disorder requiring active treatment and/or stroke 11. History of HIV infection 12. Platelet count <100,000/mm3 13. Absolute neutrophil count (ANC) <1,500/mm3 14. Hematocrit <27 percent 15. Abnormal coagulation profile (elevated PT, and/or INR, PTT) 16. Serum creatinine >2.0 mg/dL, or creatinine clearance <60 mL/min if serum creatinine 2.0 mg/dL 17. AST or ALT >1.5 x ULN 18. Bilirubin (total) >1.25 x ULN 19. Serum calcium >12.5 mg/dL 20. Active serious infection not controlled by antibiotics 21. Active angina pectoris or NY Heart Association Class III-IV heart disease 22. Karnofsky Performance Status <60% 23. Life expectancy <6 months 24. 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: 46
Location and Contact Information:
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting
Weill Medical College of Cornell University/ New York Presbyterian Hospital *Recruiting*
New York City, New York, 10021
United States
Recruiting
Additional Information:
Study ID Numbers: M59102-051;
Study Start Date: October 2003
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070837
Other Prostatic Neoplasms Studies:
1. A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
2. Massage Therapy for Cancer-Related Fatigue
3. Amifostine to Protect the Rectum during External Beam Radiotherapy for Prostate Cancer
4. Safety and Efficacy of Atrasentan in Men with Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
5. EPO906 Therapy in Patients with Prostate Cancer
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A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 in Subjects with Metastatic Androgen-Independent Prostate Cancer
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