Phase II Dutasteride in combination with CAB vs CAB in SDC (DUCT)

Phase 1

Recruiting

• Conditions: Salivary Duct Carcinoma; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500745-24-00
• Lead Sponsor: Stichting Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Pathologically/histologically proven diagnosis of (incurable) AR+ R/M salivary duct carcinoma, Adequate cardiac function, AR positive diseases (strong expression in at least 1% of nuclei of neoplastic cells based on central IHC review), Measurable disease per RECIST version 1.1 at baseline, Age = 18 years, Written informed consent must be given according to national/local regulation, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Adequate bone marrow function: (WBC = 3.5x10^9 /L; Absolute neutrophil count (ANC) = 1.5x10^9/L; Hemoglobin = 6.20 mmol/L; Platelet count = 100x10^9/L), Adequate liver function: (Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times upper limit of normal (ULN) OR = 5.0 times ULN for patients with liver metastases; Bilirubin = 1.5 times ULN. For patients known with Gilbert’s Syndrome = 3.0 times ULN is permitted), Adequate renal function: (Serum creatinine level = 1.5 times ULN or calculated creatinine clearance = 30 mL/min based on CKD-EPI-GFR)

Exclusion Criteria

Patients with history of allergic reactions attributed to compounds of similar chemical or biological composition to goserelin, bicalutamide or dutasteride, Concurrent treatment with any other anti-cancer therapy within the last 4 weeks before inclusion, Curative radiation therapy within the last 4 weeks before inclusion or palliative radiation therapy 1 week before start of study, Any condition which, in the opinion of the investigator, would preclude participation in this clinical study, Patients with peanut or soy allergy (dutasteride capsules contain lecithin which may contain soy oil), Patients who do not have adequate swallowing capacity, Patients familiar with Long QT-syndrome (LQTS), Patients (M/F) with reproductive potential not implementing adequate contraceptive measures, Patients that are pregnant or lactating, Patients with uncontrolled illness including: Cardiovascular disorders, including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias; Uncontrolled hypertension (defined as sustained systolic BP > 160 mm Hg, or diastolic BP > 100 mm Hg. Unless evidence of white-coat hypertension), Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion; Serious active infections ., Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation, Concomitant (or within 6 months before inclusion) administration of any 5-alpha reductase inhibitor, i.e. dutasteride or finasteride

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified