Phase II Dutasteride in Combination With CAB vs CAB in SDC

NCT05513365 | Recruiting Phase 2 DMC

• 2 other identifiers: MOHN221140022110057
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Salivary Duct Carcinoma

Keywords

Salivary duct carcinoma; Androgen deprivation therapy; Combined androgen blockade; Dutasteride; Goserelin; Bicalutamide; anti-androgens

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  Response will be measured according to RECIST version 1.1, the ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Duration of Response (DoR)

  Response will be measured according to RECIST version 1.1, the DoR is defined as the time from first tumor assessment at which the overall response was recorded as partial response (PR) or complete response (CR) that is subsequently confirmed until documented progressive disease (PD) or death form any cause, whichever occurs first.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary Outcomes (11)

• Progression Free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Clinical benefit rate (CBR)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Overall survival (OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Quality of Life (QoL) based on the EORTC QLQ-H&N43 questionnaire

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Study Arms (1)

Combined androgen blockade (CAB) + dutasteride

EXPERIMENTAL

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

Drug: Goserelin 10.8 mg; Drug: Bicalutamide 50 mg; Drug: Dutasteride 0.5 mg

Interventions

Goserelin 10.8 mg DRUG

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

Also known as: Zoladex

Combined androgen blockade (CAB) + dutasteride

Bicalutamide 50 mg DRUG

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

Also known as: Casodex

Combined androgen blockade (CAB) + dutasteride

Dutasteride 0.5 mg DRUG

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

Also known as: Avodart

Combined androgen blockade (CAB) + dutasteride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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)
• Serious active infections
• Patients undergoing concomitant treatments including:
• Any condition which, in the opinion of the investigator, would preclude participation in this clinical study

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 39304797 BACKGROUND

MeSH Terms

Interventions

Goserelin; bicalutamide; Dutasteride

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• C.M.L. van Herpen, prof. MD. PhD.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+31243611111; Jetty.Weijers@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 24, 2022
• Study Start: September 27, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2024-11

Locations

NL (1)