Clinical trial NCT01124786 (phase 2, status: completed)
Conditions: metastatic pancreatic adenocarcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: co-1.01, gemcitabine
SMILES: CCCCCCCC\C=C\CCCCCCCC(=O)OC[C@H]1O[C@@H](N2C=CC(N)=NC2=O)C(F)(F)[C@@H]1O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).

          -  Histological/cytological confirmation of metastatic tissue (not primary tumor) by a
             central pathology laboratory (H&E stain) to ensure sufficient material is available
             for later hENT1 analysis.

          -  Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.

          -  Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.

          -  CT scan ≤30 days prior to randomization

          -  Performance Status (ECOG) 0 or 1.

          -  Estimated life expectancy ≥ 12 weeks.

          -  Age ≥ 18 years.

          -  Adequate hematological and biological function.

          -  Written consent on an Institutional Review Board/Institutional Ethics
             Committee-approved Informed Consent Form prior to any study-specific evaluation.

        Exclusion Criteria:

          -  Prior palliative chemotherapy for pancreatic cancer.

          -  Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months
             prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or
             other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In
             both cases the patient must be sufficiently recovered and stable.

          -  Symptomatic brain metastases.

          -  Participation in other investigational drug clinical studies ≤ 30 days prior to
             randomization.

          -  Concomitant treatment with prohibited medications.

          -  History of allergy to gemcitabine or eggs.

          -  Presence of any serious or unstable concomitant systemic disorder incompatible with
             the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including
             active infection, arterial thrombosis, symptomatic pulmonary embolism).

          -  Any disorder that would hamper protocol compliance.

          -  Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated
             with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior
             malignancies are allowable irrespective of when they occurred: in situ carcinoma of
             the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and
             nonmelanotic skin cancer.

          -  Females who are pregnant or breastfeeding.

          -  Refusal to use adequate contraception for fertile patients (females and males during
             the study and for 6 months after the last study treatment). Adequate forms of
             contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly
             or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal
             ligation.

          -  Any other reason the investigator considers the patient should not participate in the
             study.