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Completed

NCT Number: NCT05694819

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
  • 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 refrain from sperm donation and stop breastfeeding during the entire study treatment period and through 3 months after the last dose of the study drug.

Exclusion criteria

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
  • Prior treatment with Darolutamide or Goserelin.
  • Metastases in the brain/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 HBV-DNA positive
  • HBcAb positive and HBV-DNA positive
  • Severe or uncontrolled concurrent heart disease or hypertension.
  • Inability to administer Darolutamide or Goserelin.

Treatment and study plan

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.

Goserelin

Drug

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

Primary outcomes

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

    Time frame: Up to 13 month

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

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

    Time frame: Up to 13 month

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

Secondary outcomes

  1. Duration of Response (DOR)

    Time frame: Up to 13 month

    DOR will be defined among responders from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease as defined in RECIST version 1.1 or death, whichever occurred first.

  2. Best Overall Response (BOR)

    Time frame: Up to 13 month

    BOR will be defined as the best response recorded from the start of protocol treatment based on RECIST version 1.1

  3. Disease Control Rate (DCR)

    Time frame: Up to 13 month

    DCR will be defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or SD for at least 6 weeks based on RECIST version 1.1.

  4. Clinical Benefit Rate (CBR)

    Time frame: Up to 13 month

    CBR will be defined as the percentage of participants who achieved a confirmed best overall response of CR, PR, or stable disease (SD) for at least 24 weeks based on RECIST version 1.1.

  5. Clinical Benefit Duration (CBD)

    Time frame: Up to 13 month

    CBD will be defined the period starting from the date of enrollment (start of treatment) and ending on the earlier of the date of determination of progression, the date of death from any cause, or the end of the study period.

  6. Progression-Free Survival (PFS)

    Time frame: Up to 13 month

    PFS will be defined as the time from the date of the initial dose of study intervention to the date of first documented disease progression as defined in the RECIST version 1.1, or death due to any cause, whichever occurred first.

  7. Overall Survival (OS)

    Time frame: Up to 13 month

    OS will be defined as the time from the date of the initial dose of study intervention to the date of the participant's death

  8. Adverse events

    Time frame: Up to 30 days after the last dose

    All adverse events, adverse events with undeniable causal relationship to the investigational drug, severe adverse events (SAEs) and SAEs with undeniable causal relationship to the investigational drug will be evaluated based on CTCAE version 5.0

  9. Quality of Life assessed using the EuroQol-5Dimention-5Level (EQ-5D-5L) questionnaire

    Time frame: Up to 30 days after the last dose

    Changes from baseline to each time point in health-related quality of life will be measured using the European Quality of Life Five Dimension Five Level Scale Assessment Questionnaire (EQ-5D-5L). The EQ-5D-5L consists of a description and a health assessment. The health description consists of five dimensions (mobility, self-care, normal activities, pain / discomfort, and anxiety / depression), with each dimension identifying five levels of severity [best (1) - worst (5)]. Health assessment is assessed using a visual analogue scale (VAS)([worse (0) - better (100)].

  10. Darolutamide monotherapy group: ORR assessed by an Independent Review Committee

    Time frame: Up to 13 month

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

  11. Darolutamide and Goserelin combination therapy group: ORR assessed by investigators

    Time frame: Up to 13 month

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

  12. Comparison of androgen receptor (AR) test results in Darolutamide and Goserelin combination therapy group

    Time frame: Baseline

    Comparison of AR test results between each institutional and a central assessment

  13. Positivity of Ki-67 in Darolutamide and Goserelin combination therapy group

    Time frame: Baseline

    The proportion of patients who have high expression of Ki-67 by a central assessment

Sponsors and collaborators

Lead sponsor

National Cancer Center Hospital East

Other

Collaborators

  • Bayer Yakuhin, Ltd.

Registry information

Official study title

Phase II Study of Darolutamide (ODM-201) in Patients With Androgen Receptor-positive Salivary Gland Carcinoma (Discovary Study)

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Jan 23, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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