Phase II Dutasteride in Combination With CAB vs CAB in SDC

Recruiting Phase 2 Interventional Study
Salivary Duct Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
26 (estimated)
Sponsor
Radboud University Medical Center · Other
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About This Trial

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.

Trial Locations
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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 I…
Contacts

C.M.L. Van Herpen, Prof. MD. PhD.

+31243611111

Jetty.Weijers@radboudumc.nl

CONTACT