Trial Title:
Phase II Dutasteride in Combination With CAB vs CAB in SDC
NCT ID:
NCT05513365
Condition:
Salivary Duct Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Ductal
Goserelin
Bicalutamide
Dutasteride
Conditions: Keywords:
Salivary duct carcinoma
Androgen deprivation therapy
Combined androgen blockade
Dutasteride
Goserelin
Bicalutamide
anti-androgens
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Patients will be included into two cohorts based on their previous treatments, either
ADT-naïve (cohort A) or ADT-resistant patients (cohort B). In cohort A, the randomization
will result in the allocation of the control arm (goserelin and bicalutamide) and
experimental arm (goserelin, bicalutamide, and dutasteride) in a 1:1 ratio. In cohort B,
patients ADT-resistant will be enrolled receiving similar therapy to the experimental
arm, i.e. goserelin, bicalutamide, and dutasteride.
Cohort A is closed for inclusion as of April 18, 2024.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Goserelin 10.8 mg
Description:
Goserelin injection (10.8 mg) once per 3 months until progressive disease, intolerable
toxicity, or investigator and/or patient decision to withdraw.
Arm group label:
Combined androgen blockade (CAB) + dutasteride
Other name:
Zoladex
Intervention type:
Drug
Intervention name:
Bicalutamide 50 mg
Description:
Bicalutamide tablets (50 mg) once daily until progressive disease, intolerable toxicity,
or investigator and/or patient decision to withdraw.
Arm group label:
Combined androgen blockade (CAB) + dutasteride
Other name:
Casodex
Intervention type:
Drug
Intervention name:
Dutasteride 0.5 mg
Description:
Dutasteride capsules (0.5 mg) once daily until progressive disease, intolerable toxicity,
or investigator and/or patient decision to withdraw.
Arm group label:
Combined androgen blockade (CAB) + dutasteride
Other name:
Avodart
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6500HB
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jetty AM Weijers, MSc
Phone:
+31243611111
Email:
Jetty.Weijers@radboudumc.nl
Investigator:
Last name:
Carla ML van Herpen, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jetty AM Weijers, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Jack A Schalken, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Gerald W Verhaegh, PhD
Email:
Sub-Investigator
Start date:
September 27, 2022
Completion date:
September 2027
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
ZonMw: The Netherlands Organisation for Health Research and Development
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05513365
