Clinical trial NCT02106884 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: nab-paclitaxel, gemcitabine
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, [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 (+ optional for TR) must be given according to ICH/GCP and
             national/local regulations.

          -  Patient is at least 18 years of age .

          -  Unresectable locally advanced or metastatic pancreatic cancer.

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas. Islet cell
             neoplasms are excluded.

          -  Evaluable or measurable disease, not in a previously irradiated area.

          -  Life expectancy of at least 12 weeks.

          -  WHO ECOG performance status ≤ 2

          -  Adequate organ function.

          -  Adequate bone marrow, hepatic and renal function. Acceptable coagulation (prothrombin
             time and partial thromboplastin time within +/- 15% of normal limits).

          -  No clinically significant abnormalities in urinalysis.

          -  Effective contraception for both male and female patients if applicable. Women of
             childbearing potential must have negative blood pregnancy test at screening visit.

        Exclusion criteria:

          -  Prior chemotherapy, radiotherapy, surgery or other investigational therapy for the
             treatment for metastatic disease. Adjuvant treatment with gemcitabine or 5-FU is
             allowed provided at least 6 months have elapsed since completion of the last dose.

          -  Major surgery within 4 weeks of the start of the study.

          -  Irradiation within 3 weeks prior to study entry.

          -  Brain metastasis (known or suspected).

          -  Serious medical risk factors involving any of the major organ systems, including high
             cardiovascular risk including coronary stenting or myocardial infarction in the last
             year and psychiatric disorders.

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

          -  History of connective tissue disorders (eg. lupus, scleroderma, arteritis nodosa,
             etc).

          -  History of interstitial lung disease.

          -  History of peripheral artery disease.

          -  Previous (within 5 years) or concurrent malignancies at other sites with the exception
             of surgically cured or adequately treated carcinoma in-situ of the cervix and basal
             cell carcinoma of the skin.

          -  Known allergy or any other adverse reaction to any of the drugs or to any related
             compound.

          -  Use of Coumadin.

          -  Organ allografts requiring immunosuppressive therapy.

          -  Pregnancy or breast-feeding.

          -  Medical, social or psychological condition which, in the opinion of the investigator,
             would not permit the patient to complete the study or sign meaningful informed
             consent.