Phase II study of Darolutamide (ODM-201) in patients with androgen receptor-positive salivary gland carcinoma

JRCT ID: jRCT2031190241

Registered date:04/03/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Androgen receptor-positive salivary gland carcinoma
• Date of first enrollment: 17/04/2020
• Target sample size: 56
• Study type: Interventional

Intervention(s)

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

Darolutamide and Goserelin combination therapy group:
Darolutamide: 600 mg (2 tablets of 300 mg) twice daily with food (equivalent to a daily dose of 1200 mg) will be administered orally
Goserelin: 3.6 mg will administered subcutaneously every 4 weeks.

Outcome(s)

Primary Outcome

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

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

Secondary Outcome

Darolutamide monotherapy group:
objective response rate(ORR) assessed by an Independent Review Committee,DOR,BOR,CBR,CBD,DCR,PFS,OS,safety,QOL(EQ-5D-5L)

Darolutamide and Goserelin combination therapy group:
objective response rate(ORR) assessed by investigators,DOR,BOR,CBR,CBD,DCR,PFS,OS,safety,QOL(EQ-5D-5L),Comparison of AR test results

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Darolutamide monotherapy group:
1.Signed, written informed consent.
2.Patients older than 20 years.
3.Histologically confirmed any of SDC, 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 through 3 months after the last dose of 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 study drug.

Exclude criteria

Darolutamide monotherapy group:
1.Histologically confirmed as androgen receptor-negative salivary gland carcinoma at central laboratory.
2.Prior treatment with AR inhibitors, CYP17 enzyme inhibitors or LH-RH analogue.
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 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 administering Darolutamide or Goserelin.

Related Information

• Primary Sponsor: Tahara Makoto
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd