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Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers

To evaluate the best overall response rate (BOR) of recurrent/metastatic androgen receptor positive (AR+) salivary gland cancer (SGC) patients with darolutamide and androgen deprivation therapy (ADT).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)

Location

North Carolina (Statewide)

What will be asked of you

Mandatory pre-treatment tumor biopsies will be performed after informed consent has been signed and before initiation of leuprolide acetate. At each visit, you will meet with a member of the study team and receive study drug(s).

In-person visits:
13

Total length of participation:
Up to 25 weeks

Looking for Specific Volunteers

Able to participate:

Must have Salivary Gland Cancer (SGC)
Must be 18 years or older
Must be willing to take study medications regularly
Must agree to pre-treatment tumor biopsies

Not eligible if:

You have not recovered from adverse events due to prior anti-cancer therapy
You have a vascular or ischemic event within 6 months of study registration
You are receiving any other investigational agents
You have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to darolutamide or leuprolide acetate. 3.2.5
You have an uncontrolled intercurrent illness.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Shetal Patel
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

23-1219

ClinicalTrials.gov

NCT05669664

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