Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)

Inclusion Criteria

• •Lead-in safety period:
• •Subjects between the age of 18 and 84 years
• •Histologically or cytologically confirmed advanced or refractory cholangiocellular carcinoma, biliary tract cancer, non-small-cell lung carcinoma, duodenal cancer, soft tissue sarcoma, ovarian carcinoma, or another non-pancreatic cancer disease indicated for gemcitabine treatment as determined by the investigator
• •Subjects who have previously received chemotherapy and standard curative or palliative care is not available, not effective, or unlikely to be effective
• •No option for surgical resection or radiation in curative intent
• •Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
• •Life expectancy of at least 3 months
• •No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• •Alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN; ≤5 x ULN for subjects with liver metastases)
• •Aspartate aminotransferase (AST) ≤3.0 x ULN (≤5 x ULN for subjects with liver involvement with cancer)
• •Total bilirubin ≤2.0 x ULN (liver metastasis \<5 x ULN)
• •Serum creatinine ≤1.5 x ULN
• •Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 10e6/L) and platelet count of 100,000 (x 10e6/L) prior to the initiation of a cycle.
• •Prothrombin time-international normalized ratio/partial thromboplastin time (PT-INR/PTT) \<1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (≤100 mg daily).
• •Women of childbearing potential must have a negative urine pregnancy test at baseline.
• •Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
• •Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
• •Subjects must be willing and able to give written informed consent.
• •Main part:
• •Subjects between the age of 18 and 84 years
• •Subjects with locally advanced or metastatic pancreatic adenocarcinoma stage III/IV indicated for gemcitabine treatment as determined by the investigator
• •No option for surgical resection or radiation in curative intent
• •Histological or cytological documentation of non-hematologic, malignant solid tumor
• •At least one measurable lesion or evaluable disease, as per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
• •Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
• •Life expectancy of at least 3 months
• •No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• •Alanine aminotransferase (ALT) \<=3.0 x upper limit of normal (ULN; \<=5 x ULN for subjects with liver metastases)
• •Aspartate aminotransferase (AST) \<=3.0 x ULN (\<=5 x ULN for subjects with liver involvement with cancer)
• •Total bilirubin \<=2.0 x ULN (liver metastasis \<=5 x ULN)
• •Serum creatinine \<=1.5 x ULN
• •Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 10e6/L) and platelet count of 100,000 (x 10e6/L) prior to the initiation of a cycle.
• •Prothrombin time-international normalized ratio/partial thromboplastin time (PT INR/PTT) \<1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (≤100 mg daily).
• •Women of childbearing potential must have a negative urine pregnancy test at baseline.
• •Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
• •Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
• •Subjects must be willing and able to give written informed consent.