Clinical trial NCT02154646 (phase 1, status: completed)
Conditions: pancreatic neoplasms
ICD codes: C25.3
Drugs: ly2157299, gemcitabine
SMILES: CC1=CC=CC(=N1)C1=NN2CCCC2=C1C1=C2C=C(C=CC2=NC=C1)C(N)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological diagnosis of adenocarcinoma of the pancreas that is
             locally advanced or metastatic and not amenable to resection with curative intent.
             These participants may have received prior chemotherapy, radiotherapy, cancer-related
             hormone therapy, or other investigational therapy as treatment or chemotherapy.

          -  Participants with previous radical surgery for pancreatic cancer are eligible after
             progression is documented.

          -  Have measurable disease or non-measurable disease, defined according to Response
             Evaluation Criteria in Solid Tumors (RECIST).

          -  Have given written informed consent prior to any study-specific procedures.

          -  Have adequate organ function.

          -  Have a performance status of less than or equal 1 on the Eastern Cooperative Oncology
             Group (ECOG).

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures.

          -  Prior radiation therapy for treatment of cancer is allowed to less than 25% of the
             bone marrow, and participants must have recovered from the acute toxic effects of
             their treatment prior to study enrollment. Prior radiation to the whole pelvis is not
             allowed.

          -  Males and females with reproductive potential: Must agree to use medically approved
             contraceptive precautions during the study and for 3 months following the last dose of
             study drug.

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days of study
             enrollment, a clinical trial involving an investigational product or nonapproved use
             of a drug or device, or concurrently enrolled in any other type of medical research
             judged not to be scientifically or medically compatible with this study.

          -  Have moderate or severe cardiac disease:

               -  Myocardial infarction within 6 months prior to study enrollment, unstable angina
                  pectoris, New York Heart Association (NYHA) Class III/IV congestive heart
                  failure, or uncontrolled hypertension.

               -  Documented major electrocardiogram (ECG) abnormalities at the investigator's
                  discretion.

               -  Major abnormalities documented by echocardiography with Doppler.

               -  Have significantly elevated brain natriuretic peptide (BNP) or elevated Troponin
                  I at screening local laboratory tests.

               -  Predisposing conditions that are consistent with development of aneurysms of the
                  ascending aorta or aortic stress.

               -  Have a history of cardiac or aortic surgery.

          -  Have known positive tests for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C virus antibodies (HCVAbs).

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis.

          -  Are unable to swallow tablets or capsules.

          -  Are pregnant or breastfeeding.

          -  Have serious preexisting medical conditions as follows:

               -  Presence or history of interstitial pneumonitis.

               -  Uncontrollable severe diabetes.

               -  Presence of serious active infection or uncontrollable chronic infection.

               -  Presence of liver cirrhosis with Child-Pugh Stage of B or C.

               -  Other serious conditions judged by the investigator.

          -  Have previous or concurrent malignancy except for basal or squamous cell skin cancer
             (non-melanoma) and/or preinvasive carcinoma of the cervix, mucosal gastrointestinal or
             uterine carcinoma, or other solid tumors treated curatively and without evidence of
             recurrence for at least 3 years prior to enrollment.

          -  Have endocrine pancreatic tumors or ampullary cancer.

          -  Have current hematological malignancies.

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY2157299.

          -  Have known allergies to LY2157299 or gemcitabine or any ingredient of LY2157299 or
             gemcitabine formulations.

          -  Are assessed as inadequate for the study by the investigator.