Phase II Dutasteride in Combination With CAB vs CAB in SDC

Recruiting now · Phase 2

Conditions studied: Salivary Duct Carcinoma

In brief

Phase 2 clinical trial on the addition of dutasteride to combined androgen blockade (CAB) therapy in recurrent and/or metastatic (R/M) salivary duct carcinoma (SDC) patients. The study included two cohorts of patients: Cohort A, which comprises ADT-naïve patients, and Cohort B, which comprises ADT-resistant patients. Cohort A is closed for inclusion as of April 18, 2024.

Key facts

Study ID

NCT05513365

Run by

Radboud University Medical Center

People needed

26

Starts

2022-09-27

Expected to finish

2027-09-01

Last updated by the study team

2025-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically/histologically proven diagnosis of (incurable) AR+ R/M salivary duct carcinoma
• 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. Appendix II.
• 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 (Appendix III).
• Adequate bone marrow function:
• WBC ≥ 3.5/10\^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
• Adequate cardiac function

You may not qualify if…

• Patients with history of allergic reactions attributed to compounds of similar chemical or biological composition to goserelin, bicalutamide or dutasteride
• 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
• Patients undergoing concomitant treatments including:
• 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
• 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

Where it is running

• Radboudumc — Nijmegen, Gelderland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.