Actively Recruiting
Phase II Dutasteride in Combination With CAB vs CAB in SDC
Led by Radboud University Medical Center · Updated on 2025-06-04
26
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Dutasteride in Combination With CAB vs CAB in SDC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of incurable androgen receptor positive recurrent or metastatic salivary duct carcinoma confirmed by pathology
- Androgen receptor positive disease with strong expression in at least 1% of tumor cell nuclei
- Measurable disease according to RECIST 1.1 criteria
- Age 18 years or older
- Able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function: WBC 6 3.5 x10^9/L, ANC 6 1.5 x10^9/L, hemoglobin 6 6.20 mmol/L, platelet count 6 100 x10^9/L
- Adequate liver function: AST and ALT 4 2.5 times upper limit of normal (ULN) or 4 5.0 times ULN if liver metastases present; bilirubin 4 1.5 times ULN (up to 3.0 times ULN for Gilbert's Syndrome)
- Adequate renal function: serum creatinine 4 1.5 times ULN or creatinine clearance 6 30 mL/min (CKD-EPI-GFR)
- Adequate cardiac function
You will not qualify if you...
- History of allergic reactions to goserelin, bicalutamide, or dutasteride or related compounds
- Allergy to peanuts or soy (dutasteride capsules may contain soy oil)
- Inability to swallow medications
- Known Long QT syndrome
- Reproductive potential without effective contraception
- Pregnancy or breastfeeding
- Uncontrolled cardiovascular conditions including symptomatic congestive heart failure, unstable angina, serious arrhythmias
- Uncontrolled hypertension (systolic >160 mm Hg or diastolic >100 mm Hg)
- Stroke, transient ischemic attack, myocardial infarction, or ischemic event within 6 months prior to study
- Serious active infections
- Use of other experimental drugs within 4 weeks prior to study
- Use of 5-alpha reductase inhibitors (e.g., dutasteride or finasteride) within 6 months prior to study
- Concurrent anti-cancer therapy within 4 weeks prior to study
- Recent curative radiation therapy within 4 weeks or palliative radiation therapy within 1 week prior to study
- Any condition deemed by the investigator to preclude study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500HB
Actively Recruiting
Research Team
C
C.M.L. Van Herpen, Prof. MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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