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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02150967
Eligibility Criteria:
Inclusion criteria:
\- Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis.
Patients with cancers of the gallbladder or ampulla of Vater are not eligible.
\- Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.
Exclusion criteria:
* Prior or current treatment with a MEK inhibitor (all Cohorts), BGJ398 (infigratinib) (all Cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).
* insufficient organ function
* Absolute Neutrophil Count (ANC) \< 1,000/mm3 \[1.0 x 10\^9/L\]
* Platelets \< 75,000/mm3 \[75 x 10\^9/L\]
* Hemoglobin \< 109.0 g/dL
* Total bilirubin \> 1.5x upper limit of normal (ULN)
* Aspartate aminotransferase/glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamic pyruvic transaminase (ALT/SGPT) \> 2.5x ULN (AST and ALT \> 5x ULN in the presence of liver metastases)
* Serum creatinine \> 1.5x ULN and a calculated or measured creatinine clearance \< 45 mL/min
* Inorganic phosphorus outside of normal limits
* Total and ionized serum calcium outside of normal limits
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02150967
Study Brief:
Protocol Section:
NCT02150967