Phase II Dutasteride in Combination With CAB vs CAB in SDC

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 will include two cohorts of patients: Cohort A, which comprises ADT-naïve patients, and Cohort B, which comprises ADT-resistant patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University Medical Center
• Treatments: Bicalutamide; Dutasteride; Goserelin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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