At a glance
ClinicalIndex Comparison Record- ✓Pathologically/histologically confirmed diagnosis of unresectable/metastatic salivary duct carcinoma
- ✓Androgen receptor positive by central IHC (≥1% nuclear expression in neoplastic cells)
- ✓Measurable disease by RECIST v1.1 at baseline
- ✓Age ≥18 years
- ✕History of allergic reactions to goserelin, bicalutamide, or dutasteride
- ✕Peanut or soy allergy (dutasteride contains soy-derived lecithin)
- ✕Inadequate swallowing capacity
- ✕Family history of Long QT syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05513365Phase 2RecruitingUpdate OverdueUpdated 12mo ago · Completion was 9mo agoA Randomized Phase II Trial on the Addition of Dutasteride to Combined Androgen Blockade Therapy Versus Combined Androgen Blockade Therapy Alone in Patients With Recurrent and/or Metastatic Salivary Duct Carcinoma - DUCT Study
In Brief
A Phase 2 clinical trial evaluating Goserelin 10.8 mg, Bicalutamide 50 mg, and 1 other intervention for Salivary Duct Carcinoma. Currently recruiting, targeting 26 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Goserelin injection (10.8 mg) once per 3 months until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.
Bicalutamide tablets (50 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.
Dutasteride capsules (0.5 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.