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Brief Title: A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer
Official Title: A Phase II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Aplidin® as a 3-hour IV Infusion Every 2 Weeks, in Relapsing or Refractory Patients With Androgen-independent Prostate Adenocarcinoma..
Study ID: NCT00780975
Brief Summary: This is a study to test the safety and efficacy of an investigational chemotherapy agent in patients with advanced prostate cancer. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the investigator conducting the study.
Detailed Description: Prostate cancer is the most common non-cutaneous cancer diagnosed in men in the United States. The majority of deaths occur in men with androgen-independent prostate cancer \[AIPC\]. Although 80% of men with advanced cancer will initially respond to androgen ablation with disease regression or stabilization, their malignancies become resistant to such therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Celestia Higano, M.D.
Affiliation: Seattle Cancer Care Alliance
Role: PRINCIPAL_INVESTIGATOR
Name: Maha Hussain, M.D.
Affiliation: University of Michigan Rogel Cancer Center
Role: PRINCIPAL_INVESTIGATOR