Clinical trial NCT01028495 (phase 2, status: completed)
Conditions: metastatic pancreatic cancer
ICD codes: C25.3
Drugs: rx-0201 plus gemcitabine
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent prior to the initiation of study procedures.

          -  Are > 18 years of age

          -  Have metastatic pancreatic cancer.

          -  Have at least 1 measurable lesion by RECIST criteria.

          -  Have a Karnofsky Performance Status of > 70.

          -  Have at least a 6-month life expectancy as assessed by the investigator.

          -  Pre-menopausal women must be surgically sterile or agree to use an accepted method of
             birth control while participating in the study and for 30 days following the last
             exposure of study drug. Acceptable forms of birth control are: hormonal contraceptives
             (oral, injectable, transdermal or implant), double-barrier contraceptives (condom or
             diaphragm with spermicide), and intrauterine device (IUD).

          -  Male subjects need to either be surgically sterile or agree to use a barrier method of
             birth control described above during the study and for 30 days following the last
             exposure to study drug. The subject's agreed upon method of birth control will be
             discussed and documented in the subjects source document during the screening phase of
             the study.

        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:

               -  Hemoglobin < 8.0 grams/deciliter (g/dL)

               -  Absolute neutrophil count (ANC) < 1500/microliter (μL)

               -  Platelet count < 100,000/μL

               -  Serum creatinine > 1.5 x the institutional upper limit of normal (IULN)
                  creatinine.

               -  Serum bilirubin > 1.5 X IULN

               -  Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) > 2
                  x IULN (> 5 x IULN in presence of known liver metastasis)

               -  Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) > 2 x
                  IULN (> 5 x IULN in presence of known liver metastasis)

               -  Have a prothrombin time >1.25 x IULN on screening laboratory assessments.

               -  HCV or HBsAg positive subjects

          -  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.