NCT00780975

A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer

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..

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: PharmaMar · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Aplidin (plitidepsin)	Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-10-28
• Last updated: 2020-11-24
• Results posted: 2020-11-24

Locations

2 sites across 1 country: United States