Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02117258
Eligibility Criteria:
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02117258
Study Brief:
Protocol Section:
NCT02117258