Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

NCT05694819 | Completed Phase 2 DMC

• 2 other identifiers: YCU19003jRCT2031190241
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 12

Brief Summary

This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen receptor-positive salivary gland carcinoma.

Conditions

Salivary Gland Cancer

Keywords

Androgen receptor (AR)-positive; Salivary gland carcinoma; Darolutamide; luteinizing hormone-releasing hormone (LH-RH) analogue

Outcome Measures

Primary Outcomes (2)

• Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators

  The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators

  Up to 13 month

• Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee

  The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee

  Up to 13 month

Secondary Outcomes (13)

• Duration of Response (DOR)

  Up to 13 month

• Best Overall Response (BOR)

  Up to 13 month

• Disease Control Rate (DCR)

  Up to 13 month

• Clinical Benefit Rate (CBR)

  Up to 13 month

• Clinical Benefit Duration (CBD)

  Up to 13 month

Study Arms (2)

Darolutamide monotherapy

EXPERIMENTAL

Targeted patients: 24

Drug: Darolutamide

Darolutamide plus Goserelin

EXPERIMENTAL

Targeted patients: 32

Drug: Darolutamide; Drug: Goserelin

Interventions

Darolutamide DRUG

Darolutamide at a dose of 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally.

Darolutamide monotherapy; Darolutamide plus Goserelin

Goserelin DRUG

Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.

Darolutamide plus Goserelin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Darolutamide monotherapy group:
• Signed, written informed consent.
• Patients older than 20 years.
• Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma (AC)(NOS), or Carcinoma ex pleomorphic adenoma.
• Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
• Presence of measurable or evaluable disease according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate organ or bone marrow function
• Patients who agree to practice effective barrier contraception and refrain from sperm donation during the entire study treatment period and 3 months after the last dose of the study drug.
• Darolutamide and Goserelin combination therapy group:
• Signed, written informed consent.
• Patients older than 20 years.
• Histologically confirmed as androgen receptor-positive salivary gland carcinoma at the medical institution.
• Histologically confirmed as salivary gland carcinoma at the medical institution.
• Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.

You may not qualify if:

• Darolutamide monotherapy group:
• Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.
• Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
• Metastases in the brain/central nervous system (CNS).
• Patients who are pregnant or breastfeeding.
• Synchronous or metachronous malignancies.
• Participant has a known history of HIV infection.
• A positive test result for any of the followings:
• HBsAg positive
• HBsAb positive and hepatitis B virus (HBV)-DNA positive
• HBcAb positive and HBV-DNA positive
• Severe or uncontrolled concurrent heart disease or hypertension.
• Inability to swallow oral medications.
• Darolutamide and Goserelin combination therapy group:
• Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex Hormones, or Gonadotropin

Sponsors & Collaborators

• National Cancer Center Hospital East: lead
• Bayer Yakuhin, Ltd.: collaborator

Study Sites (12)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Chiba University Hospital

Chiba, Chiba, 260-8677, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

The Jikei University Hospital

Tokyo, Tokyo, 105-0003, Japan

Location

Tokyo Medical And Dental University Hospital

Tokyo, Tokyo, 113-8519, Japan

Location

Tokyo Medical University Hospital

Tokyo, Tokyo, 160-0023, Japan

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Bulbo-Spinal Atrophy, X-Linked

Interventions

darolutamide; Goserelin

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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

Study Officials

• Makoto Tahara, MD, PhD

  National Cancer Center Hospital East

  STUDY DIRECTOR

• Naomi Kiyota, MD, PhD

  Kobe University Hospital

  STUDY CHAIR

• Susumu Okano, MD, PhD

  National Cancer Center Hospital East

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Head and Neck Medical Oncology

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: April 17, 2020
• Primary Completion: August 9, 2024
• Study Completion: March 23, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (12)