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Phase II Dutasteride in Combination With CAB vs CAB in SDC

NCT05513365 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-06-04

No results posted yet for this study

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.

Conditions

  • Salivary Duct Carcinoma

Interventions

DRUG

Goserelin 10.8 mg

Goserelin injection (10.8 mg) once per 3 months until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

DRUG

Bicalutamide 50 mg

Bicalutamide tablets (50 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

DRUG

Dutasteride 0.5 mg

Dutasteride capsules (0.5 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • C.M.L. van Herpen, prof. MD. PhD. · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513365 on ClinicalTrials.gov