Trial information
A Study of Epothilone D in Patients With Metastatic Prostate Cancer
Status: Completed
Protocol number: NO18401
Sponsor: Hoffmann-La Roche Inc
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of repeated cycles of intravenous Epothilone D on treatment response in patients with hormone-resistant prostate cancer who have progressed following initial therapy for metastatic disease
Brief summary: A study to assess the efficacy and safety of repeated cycles of intravenous Epothilone D in patients whose hormone resistant prostate cancer has progressed after initial treatment for metastatic disease. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Target sample size is
39.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Prostate Cancer
Intervention type: Drug
Intervention name: Epothilone D
Primary outcome: 1. Efficacy: PSA response rate, objective response rate, time to tumor progression, time to PSA progression, duration of PSA and tumor response, and survival
Key secondary outcomes: 1. Safety: Adverse events, neurological evaluations, and laboratory tests
Inclusion criteria:
- adult patients >=18 years of age;
- histologically confirmed prostate cancer with radiographically documented metastatic disease;
- previous androgen deprivation therapy;
- surgically sterile, or prepared to use an effective contraception.
Exclusion criteria:
- second-line chemotherapy regimen for metastatic disease;
- known central nervous system metastases requiring corticosteroids.
Gender: Males
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
