Status:
COMPLETED
Phase II, 2nd Line Melanoma - RAND Monotherapy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), ...
Eligibility Criteria
Inclusion
- Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
- Men and women, who are at least 18 years of age
Exclusion
- Ocular or mucosal melanoma
- Complete surgical resection of all identifiable sites of disease
- Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00612664
Start Date
March 1 2008
End Date
October 1 2009
Last Update
October 12 2015
Active Locations (32)
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1
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
2
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
3
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
4
Indiana University Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202