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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01971034
Eligibility Criteria:
Inclusion Criteria:
* Pancreatic advanced or metastatic adenocarcinoma histologically confirmed.
* Previously treatment with gemcitabine as adjuvant or metastatic disease.
* Clinical or radiological evidence of disease progression, determined by physician. Is not mandatory RECIST (Response Evaluation Criteria in Solid Tumors) evaluation to determine the progression of disease before the study inclusion.
* Patient with intolerance to gemcitabine, even without disease progression, are also eligible.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* At least 10 weeks of life expectation.
* Adequate organ function defined as:
* Serum AST (aspartate aminotransferase) and ALT (alanine aminotransferase)≤ 2.5 × ULN (upper normal limit)
* Total Bilirubin ≤ 2,0 x ULN
* Absolute neutrophil count ≥ 1,500/ mm3
* Platelets ≥100.000/ mm3
* Hemoglobin ≥ 8,0 g/dl
* Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min
* Signed written informed consent.
Exclusion Criteria:
* Major surgical procedure within 4 weeks of the beginning of the treatment.
* History of serious clinical or psychiatric disease.
* Symptomatic hypoglycemia at the screening visit.
* Target lesion radiotherapy within 4 weeks of the beginning of the treatment.
* Treatment with any anti-cancer investigational drug.
* Treatment with any IGF-I or IGFR-I
* Treatment with metformin within 12 months prior to commencing study treatment
* For female patients, current pregnancy and/or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01971034
Study Brief:
Protocol Section:
NCT01971034