Phase II Dutasteride in Combination With CAB vs CAB in SDC (DUCT)

Radboud University Medical Center

Status and phase

Enrolling

Phase 2

Conditions

Salivary Duct Carcinoma

Treatments

Drug: Bicalutamide 50 mg

Drug: Goserelin 10.8 mg

Drug: Dutasteride 0.5 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05513365

MOHN22

1140022110057 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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