Status:
COMPLETED
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Lead Sponsor:
Bayer
Collaborating Sponsors:
Amgen
Conditions:
Cancer
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib ...
Eligibility Criteria
Inclusion
- Patients who have a life expectancy of at least 12 weeks
- Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
- Patients who have an ECOG PS of 0, or 1
- Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
Exclusion
- Primary ocular or mucosal melanoma
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 3 years prior to study entry
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00110994
Start Date
April 1 2005
End Date
March 1 2008
Last Update
June 8 2015
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Tucson, Arizona, United States, 85724
2
Aurora, Colorado, United States, 80045
3
Lakeland, Florida, United States, 33805
4
Park Ridge, Illinois, United States, 60068