EPO906 Therapy in Patients With Advanced Melanoma
- Registration Number
- NCT00035165
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EPO906 epothilone b -
- Primary Outcome Measures
Name Time Method Tumor response (complete response (CR), partial response (PR), stable disease (SD)) at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle) Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.
- Secondary Outcome Measures
Name Time Method Number and percentage of patients with Adverse events as necessary Safety and tolerabilty of EPO906: Safety assessments consisted of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance status.
Objective response rate (ORR) at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle) Time to disease progression (TTP) at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle) Overall Survival (OS) from the date of the first dose of treatment to date of death from any cause, or the last date the patient is known to be alive Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment For biomarker development
Trial Locations
- Locations (6)
Comprehensive Cancer Center@ Our Lady if Mercy Medical Center
🇺🇸Bronx, New York, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Oklahoma Oncology, Inc.
🇺🇸Tulsa, Oklahoma, United States
UPMC Health Systems
🇺🇸Pittsburgh, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States