Phase II Dutasteride in Combination With CAB vs CAB in SDC

NCT ID: NCT05513365

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-27
• Study Completion Date: 2027-09-30

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.

Detailed Description

A prospective, randomized controlled, single-institution, phase II clinical trial to assess the objective response rate (ORR), duration of response (DoR), progression free survival (PFS), overall survival (OS), toxicity, quality of life (QoL), and expression of molecular targets of patients with R/M SDC treated with either combined androgen blockade (CAB; goserelin + bicalutamide) or CAB + dutasteride, Participants in Cohort A will be randomized 1:1 at the study entry to receive CAB (goserelin 10.8 mg/3months + bicalutamide 50 mg/once daily) or CAB + dutasteride (0.5 mg/once daily). Participants will receive treatment until until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Cohort A is closed for inclusion as of April 18, 2024.

Conditions

Salivary Duct Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined androgen blockade (CAB) + dutasteride

Patients from cohort B (ADT-resistant) will receive CAB+dutasteride.

Group Type: EXPERIMENTAL

Goserelin 10.8 mg

Intervention Type: DRUG

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

Bicalutamide 50 mg

Intervention Type: DRUG

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

Dutasteride 0.5 mg

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Bicalutamide 50 mg

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Zoladex; Casodex; Avodart

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C.M.L. van Herpen, prof. MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

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

Role: CONTACT

Jetty.Weijers@radboudumc.nl

+31243611111

Facility Contacts

Jetty AM Weijers, MSc

Role: primary

Jetty.Weijers@radboudumc.nl

+31243611111

References

Weijers 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.

Reference Type: BACKGROUND

PMID: 39304797 (View on PubMed)

Other Identifiers

1140022110057

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MOHN22

Identifier Type: -

Identifier Source: org_study_id