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Keep this study
Lead
Zeria Pharmaceutical
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1\. Subjects with histological or cytological evidence of metastatic Pancreatic Adenocarcinoma, Measurable disease or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version criteria
2\. Subjects with a life expectancy of at least 12 weeks,
3\. Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2,
4\. Subjects with the following adequate organ functions:
* White blood cell count ≥3,000/μL (or absolute neutrophil count ≥1,500/μL) and ≤ 12,000/μL ,
* Platelet count ≥100.0 × 10\^9/L,
* Hemoglobin ≥9.0 g/dL,
* Serum creatinine ≤1.5 × the upper limit normal (ULN),
* Total bilirubin ≤2.0 × ULN,
* Serum aspartate transaminase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases), and
* Serum alanine aminotransferase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases).
You may not be if
Subjects received the following previous therapies for Pancreatic Adenocarcinoma:
* Surgery within the 4 weeks prior to randomization,
* Radiation and chemoradiation within the 12 weeks prior to randomization,
* Radiation for pain relief within the 4 weeks prior to randomization,
* Gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization,
* Chemotherapy except GEM used as an adjuvant on surgery within the 4 weeks prior to randomization,
* Gemcitabine ≥600 mg/m\^2 as sensitizer for chemoradiation,
* Gemcitabine \<600 mg/m\^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization,
* Gemcitabine used for systemic chemotherapy, or
* Systemic chemotherapies except GEM within the 4 weeks prior to randomization.
Clareo Health | Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma
