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Androgen Receptor Inhibitor
Darolutamide for Salivary Gland Cancer
Phase 2
Recruiting
Led By Alan L Ho
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests a drug combo to treat salivary cancer that has spread or returned. The drugs block male hormones to stop cancer growth.
Who is the study for?
Adults with advanced salivary gland cancer that has spread, can't be surgically removed, or has returned after treatment. Participants must have tumors responsive to androgen (a male hormone), measurable disease, acceptable organ function, no prior androgen-targeted therapy (except under certain conditions), and an ECOG performance status of <=2. They should not have severe heart issues or other illnesses that could affect the trial's safety.Check my eligibility
What is being tested?
The trial is testing darolutamide combined with leuprolide acetate in patients with salivary gland cancer driven by androgens. Darolutamide blocks the effects of androgens on cancer cells while leuprolide decreases hormone levels in the body. The goal is to see if this combination can stop tumor growth or shrink them.See study design
What are the potential side effects?
Potential side effects include those common to anti-androgen therapies such as fatigue, hot flashes, decreased libido, gastrointestinal disturbances like nausea or diarrhea, potential liver changes reflected in blood tests without symptoms usually reversible upon stopping medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response (BOR)
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Differences in BOR, PFS, OS in patients who did and did not receive prior systemic therapy for androgen receptor positive salivary gland cancer
Molecular, genomic, and transcriptomic biomarkers
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (darolutamide, leuprolide acetate)Experimental Treatment6 Interventions
Patients receive darolutamide PO BID on days 1-28 of each cycle and leuprolide acetate IM every 4 or 12 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, collection of blood samples, and CT/MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biopsy
2014
Completed Phase 4
~1090
Darolutamide
2018
Completed Phase 2
~100
Biospecimen Collection
2004
Completed Phase 2
~1730
Leuprolide Acetate
2002
Completed Phase 3
~1890
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,925,985 Total Patients Enrolled
Alan L HoPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
3 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatment for brain metastases.My tumor can be safely biopsied.I agree to use effective birth control or abstain from sex during the study.I can take care of myself but might not be able to do heavy physical work.My hepatitis B virus load is undetectable with treatment.I have had a stroke or heart attack in the last 6 months.I have moderate liver problems.I haven't had AR-targeted therapy for my current cancer, except as part of early treatment with a recurrence after 6+ months.I am 18 years old or older.My salivary gland cancer is advanced, cannot be surgically removed, and tests positive for AR.I am HIV positive, on treatment, and my viral load is undetectable.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have another cancer, but it won't affect this trial's treatment.I have recovered from side effects of previous cancer treatments, except for hair loss or nerve issues.My kidney function, measured by GFR, is adequate.My heart is healthy enough for this trial, meeting the NYHA class 2B or better.I am not taking medication that strongly affects how my body processes drugs.I am allergic to medications similar to darolutamide or leuprolide.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (darolutamide, leuprolide acetate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are associated with utilizing the darolutamide and leuprolide acetate treatment regimen?
"Our team at Power assigned a score of 2 to Treatment (darolutamide, leuprolide acetate) due to the lack of efficacy data available as this is only in Phase 2 trials."
Answered by AI
Is enrollment in this experiment accessible to participants at the present moment?
"Affirmative. According to the data found on clinicaltrials.gov, this medical trial is actively recruiting patients since its original posting date of April 14th 2023 and subsequent updates made at the end of that same month. With a total sample size of 20 individuals across one location, enrolment is still in progress."
Answered by AI
How many volunteers are participating in this medical experiment?
"Affirmative. The clinicaltrials.gov website attests to the active recruitment of participants for this medical trial, which was initially posted on April 14th 2023 and recently refreshed on April 29th 2023. This research endeavour requires the enlistment of twenty people from a single location."
Answered by AI
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