A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
Status: | Archived |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | May 2009 |
End Date: | May 2011 |
A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine,
in subjects with metastatic pancreatic cancer.
Subjects enrolled to assess safety will receive a combination of Gemcitabine plus RX-0201.
Gemcitabine will be administered prior to RX-0201 intravenously in a 30-min iv infusion dose
at 1000 mg/m2 once weekly for up to 2 cycles; each 4-week cycle consist of 3-week treatment
phase followed by 1 week resting phase. RX-0201 will be administered at 250 mg/m2/day in a
24-hour continuous intravenous infusion for up to 2 cycles; each 3-week cycle consists of
2-week treatment phase followed by a 1 week resting phase. (See schedule of
assessments)Subjects enrolled to evaluate efficacy will receive a combination of Gemcitabine
and RX-0201 as outline above for up to 4 cycles.
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