Clinical trial · Interventional
Phase II Dutasteride in Combination With CAB vs CAB in SDC
A 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
NCT05513365CI-TRIAL-00090551DUCTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Salivary Duct Carcinoma | Salivary Duct Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide 50 mg | Drug | Bicalutamide | ALIAS |
| Dutasteride 0.5 mg | Drug | — | UNRESOLVED |
| Goserelin 10.8 mg | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined androgen blockade (CAB) + dutasteride
- description
- Patients from cohort B (ADT-resistant) will receive CAB+dutasteride.
- interventionNames
- Drug: Goserelin 10.8 mg
- Drug: Bicalutamide 50 mg
- Drug: Dutasteride 0.5 mg
Primary outcomes (2)
- measure
- Overall Response Rate (ORR)
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
- description
- Response will be measured according to RECIST version 1.1, the ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.
- measure
- Duration of Response (DoR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDWeijers JAM, Verhaegh GW, Lassche G, van Engen-van Grunsven ACH, Driessen CML, van Erp NP, Jonker MA, Schalken JA, van Herpen CML. A randomized phase II trial on the addition of dutasteride to combined androgen blockade therapy versus combined androgen blockade therapy alone in patients with advanced or metastatic salivary duct carcinoma - the DUCT study protocol. BMC Cancer. 2024 Sep 20;24(1):1174. doi: 10.1186/s12885-024-12889-0. PMID 39304797