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Trial Title:
Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)
NCT ID:
NCT05694819
Condition:
Salivary Gland Cancer
Conditions: Official terms:
Carcinoma
Salivary Gland Neoplasms
Goserelin
Conditions: Keywords:
Androgen receptor (AR)-positive
Salivary gland carcinoma
Darolutamide
luteinizing hormone-releasing hormone (LH-RH) analogue
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Darolutamide
Description:
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.
Arm group label:
Darolutamide monotherapy
Arm group label:
Darolutamide plus Goserelin
Intervention type:
Drug
Intervention name:
Goserelin
Description:
Goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks.
Arm group label:
Darolutamide plus Goserelin
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Darolutamide monotherapy group:
1. Signed, written informed consent.
2. Patients older than 20 years.
3. Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma
(AC)(NOS), or Carcinoma ex pleomorphic adenoma.
4. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma
who are not applied for surgery or radiation treatment.
5. Presence of measurable or evaluable disease according to RECIST v1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7. Adequate organ or bone marrow function
8. 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:
1. Signed, written informed consent.
2. Patients older than 20 years.
3. Histologically confirmed as androgen receptor-positive salivary gland carcinoma at
the medical institution.
4. Histologically confirmed as salivary gland carcinoma at the medical institution.
5. Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma
who are not applied for surgery or radiation treatment.
6. Presence of measurable or evaluable disease according to RECIST v1.1
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
8. Adequate organ or bone marrow function
9. 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:
1. Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a
central laboratory.
2. Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
3. Metastases in the brain/central nervous system (CNS).
4. Patients who are pregnant or breastfeeding.
5. Synchronous or metachronous malignancies.
6. Participant has a known history of HIV infection.
7. 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
8. Severe or uncontrolled concurrent heart disease or hypertension.
9. Inability to swallow oral medications.
Darolutamide and Goserelin combination therapy group:
1. Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex
Hormones, or Gonadotropin
2. Prior treatment with Darolutamide or Goserelin.
3. Metastases in the brain/CNS.
4. Patients who are pregnant or breastfeeding.
5. Synchronous or metachronous malignancies.
6. Participant has a known history of HIV infection.
7. A positive test result for any of the followings:
- HBsAg positive
- HBsAb positive and HBV-DNA positive
- HBcAb positive and HBV-DNA positive
8. Severe or uncontrolled concurrent heart disease or hypertension.
9. Inability to administer Darolutamide or Goserelin.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nagoya University Hospital
Address:
City:
Nagoya
Zip:
466-8560
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Facility:
Name:
Kobe University Hospital
Address:
City:
Kobe
Zip:
650-0017
Country:
Japan
Facility:
Name:
Yokohama City University Hospital
Address:
City:
Yokohama
Zip:
236-0004
Country:
Japan
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai
Zip:
980-8574
Country:
Japan
Facility:
Name:
Chiba University Hospital
Address:
City:
Chiba
Zip:
260-8677
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Medical Center
Address:
City:
Fukuoka
Zip:
810-8563
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Facility:
Name:
The Jikei University Hospital
Address:
City:
Tokyo
Zip:
105-0003
Country:
Japan
Facility:
Name:
Tokyo Medical And Dental University Hospital
Address:
City:
Tokyo
Zip:
113-8519
Country:
Japan
Facility:
Name:
Tokyo Medical University Hospital
Address:
City:
Tokyo
Zip:
160-0023
Country:
Japan
Start date:
April 17, 2020
Completion date:
February 2026
Lead sponsor:
Agency:
National Cancer Center Hospital East
Agency class:
Other
Collaborator:
Agency:
Bayer Yakuhin, Ltd.
Agency class:
Industry
Source:
National Cancer Center Hospital East
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05694819
