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 ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Novartis Investigative Site
New Brunswick, New Jersey, United States
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Enschede, Netherlands, Netherlands
Novartis Investigative Site
Amsterdam, Netherlands
Tumor response rate
tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: Every 2 cycles
Time to disease progression
Time frame: from start of treatment to documented disease progression, death from study indication, or the date of last follow-up
Overall survival
Time frame: measured from the start of treatment to the date of death or the last date the patient was known to be alive.
Duration of response
duration of response in patients with complete response (CR) or partial response (PR)
Time frame: Every 3 months
recording all adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations
Time frame: Every 3 months
pharmacogenetic analyses with blood and tumor samples from these patients
Time frame: Every 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Zwolle, Netherlands
Novartis Investigative Site
Bratislava, Slovakia
Novartis Investigative Site
Košice, Slovakia
Novartis Investigative Site
Surrey, United Kingdom