CAPECITABINE for Salivary duct carcinoma

Inclusion criteria

• {"criterion_text":"- Pathologically/histologically proven diagnosis of (incurable) R/M SDC\n- Adequate renal function (Serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 30 ml/min)\n- Written informed consent\n- In case of AR+ HER2- disease: progression on or unwillingness to receive androgen blockade\n- In case of AR+ HER2+ (IHC 3+ or IHC 2+ with positive ISH) disease: progression on anti-HER2 therapy and progression on or unwillingness to receive androgen blockade\n- Progression on carboplatin-paclitaxel or unfit for carboplatin/paclitaxel\n- Patients with measurable disease per RECIST v1.1 (Appendix I) or patients with bone metastases only who do not meet the criteria for measurable disease per RECIST v1.1\n- Age ≥ 18 years\n- ECOG 0-1\n- Adequate bone marrow function (neutrophils ≥2.0 × 109/l, platelets ≥100 × 109/l, hemoglobin ≥5.8 mmol/l)\n- Adequate liver function (total bilirubin ≤1.5 x upper limit of normal (ULN). For patients known with Gilbert’s Syndrome ≤ 3 x ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN or ≤5.0 × ULN for patients with liver metastases)"}

Exclusion criteria

• {"criterion_text":"- History of severe fluoropyrimidine hypersensitivity\n- Total absence of DPD-activity\n- Usage of DPD-inhibitors within 4 weeks before start of treatment\n- Inadequate swallowing capacity\n- Patient with reproduction potential not implementing contraceptive measures\n- Pregnancy or lactating women\n- Uncontrolled illness\n- Undergoing concomitant cancer treatments"}

Primary endpoints

• {"endpoint_text":"- Best Overall Respone Rate","definition_or_measurement_approach":"No detailed definition provided in the primary endpoint entry. Inclusion criteria require 'Patients with measurable disease per RECIST v1.1 (Appendix I)', indicating assessment of response will use RECIST v1.1 for patients with measurable disease."}

Secondary endpoints

• {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":"No definition provided in the endpoint entry."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"No definition provided in the endpoint entry."}
• {"endpoint_text":"- Clinical benefit rate","definition_or_measurement_approach":"No definition provided in the endpoint entry."}
• {"endpoint_text":"- Disease control rate","definition_or_measurement_approach":"No definition provided in the endpoint entry."}
• {"endpoint_text":"- Safety","definition_or_measurement_approach":"No definition provided in the endpoint entry."}
• {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"No definition provided in the endpoint entry."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

10-03-2025

Processing Time Days

53

Number Of Sites

1

Number Of Participants

17

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands