NCT05513365 Phase II Dutasteride in Combination With CAB vs CAB in SDC
| NCT ID | NCT05513365 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Radboud University Medical Center |
| Condition | Salivary Duct Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2022-09-27 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 26 participants in total. It began in 2022-09-27 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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 (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
Contact & Investigator
C.M.L. van Herpen, prof. MD. PhD.
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT05513365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Salivary Duct Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05513365 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05513365 currently recruiting?
Yes, NCT05513365 is actively recruiting participants. Contact the research team at Jetty.Weijers@radboudumc.nl for enrollment information.
Where is the NCT05513365 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT05513365 clinical trial?
NCT05513365 is sponsored by Radboud University Medical Center. The principal investigator is C.M.L. van Herpen, prof. MD. PhD. at Radboud University Medical Center. The trial plans to enroll 26 participants.