Status and phase
Conditions
Treatments
About
To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine, in subjects with metastatic pancreatic cancer.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Are unwilling or unable to provide informed consent.
Are unwilling or unable to comply with the requirements of the protocol.
Have been treated with another investigational agent for pancreatic cancer.
Have any of the following screening laboratory values:
Have received therapeutic dose of either warfarin or heparin within 21 days before Day 1 (the first day of dosing; prophylactic use of warfarin or heparin) to maintain patency of indwelling IV catheters/lines is allowed
Have a history of brain cancer (primary or metastatic).
Have a history of an active hematologic malignancy within the past 2 years.
Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV).
Have a serious infection requiring intravenous antibiotic therapy during screening.
Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period.
Primary purpose
Allocation
Interventional model
Masking
31 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal