A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
7 Months
No
Margaret Tempero, M.D
Study Chair
United States: Food and Drug Administration
RX-0201-P2-A-07
NCT01028495
May 2009
August 2012
Name | Location |
---|---|
Texas Oncology, P.A. | Dallas, Texas 75246 |
Texas Oncology | Dallas, Texas |
Baptist Cancer Institute | Jacksonville, Florida 32207 |
Orchard Healthcare Research Inc. | Skokie, Illinois 60076 |