Clinical trial NCT01272791 (phase 2, status: completed)
Conditions: metastatic pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent has been obtained.

          -  Adults of 18 years of age or older with a life expectancy of at least 3 months.

          -  Patients with histologically or cytologically documented stage IV ductal
             adenocarcinoma of the pancreas.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          -  Adequate hematologic function (ANC ≥ 1,500 cells/µL; hemoglobin ≥ 9 g/dL, platelets ≥
             100,000/µL).

          -  Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine
             clearance ≥ 60 mL/min).

          -  Adequate hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN); ALT
             and AST may be <5 x ULN if due to liver metastases.

          -  PT/INR ≤ 1.5 × ULN.

          -  aPTT ≤ 1.5 × ULN.

          -  Female patients must have a negative urine or serum pregnancy test at screening
             (pregnancy test not required for patients with bilateral oophorectomy and/or
             hysterectomy or for those patients who are > 1 year postmenopausal).

          -  All patients of reproductive potential must agree to use an approved form of
             contraception (as determined by the investigator).

        Exclusion Criteria:

          -  Neuroendocrine tumors (carcinoid, islet cell cancer) of the pancreas.

          -  NYHA Class III or IV, cardiac function, myocardial infarction within 6 months prior to
             Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease.

          -  Known brain, leptomeningeal or epidural metastases.

          -  Radiation therapy within 7 days of Study Day 1, lack of recovery from previous
             therapeutic radiation, or planned radiation therapy during the study period.

          -  Previously received any systemic treatment for pancreatic cancer, including prior
             neoadjuvant or adjuvant chemotherapy for lower stage disease.

          -  Previously malignancies, except for adequately treated non-melanoma skin cancer, in
             situ cancer, or other cancer from which the subject has been disease-free for at least
             5 years.

          -  Severe chronic obstructive or other pulmonary disease with hypoxemia.

          -  Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without
             complete recovery.

          -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
             therapy.

          -  Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose
             anticoagulants to maintain patency of lines are eligible.

          -  Venous thromboembolic events (e.g. deep vein thrombosis or pulmonary embolism) within
             6 months of screening.

          -  QTC interval of >470 ms on screening.

          -  Long QT syndrome or family history of sudden cardiac death in young family members.

          -  Subjects who participated in an investigational drug or device study within 28 days
             prior to study entry.

          -  Known active infection with HIV, hepatitis B, or hepatitis C.

          -  Females who are pregnant or breast-feeding.

          -  Concomitant disease or condition that could interfere with the conduct of the study,
             or that would, in the opinion of the investigator, pose an unacceptable risk to the
             subject in this study.

          -  Unwillingness or inability to comply with the study protocol for any reason.