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

NCT05694819 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-04-08

No results posted yet for this study

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

Interventions

DRUG

Darolutamide

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.

DRUG

Goserelin

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

Sponsors & Collaborators

  • Bayer Yakuhin, Ltd.

    collaborator INDUSTRY

  • National Cancer Center Hospital East

    lead OTHER

Principal Investigators

  • Makoto Tahara, MD, PhD · National Cancer Center Hospital East

  • Naomi Kiyota, MD, PhD · Kobe University Hospital

  • Susumu Okano, MD, PhD · National Cancer Center Hospital East

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2024-08-09
Completion
2026-03-23

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05694819 on ClinicalTrials.gov