Trial Title:
Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers
NCT ID:
NCT05669664
Condition:
Locally Advanced Salivary Gland Carcinoma
Metastatic Salivary Gland Carcinoma
Recurrent Salivary Gland Carcinoma
Unresectable Salivary Gland Carcinoma
Conditions: Official terms:
Carcinoma
Salivary Gland Neoplasms
Leuprolide
Androgen Antagonists
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (darolutamide, leuprolide acetate)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood
Arm group label:
Treatment (darolutamide, leuprolide acetate)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (darolutamide, leuprolide acetate)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Darolutamide
Description:
Given PO
Arm group label:
Treatment (darolutamide, leuprolide acetate)
Other name:
Antiandrogen ODM-201
Other name:
BAY 1841788
Other name:
BAY-1841788
Other name:
BAY1841788
Other name:
Nubeqa
Other name:
ODM 201
Other name:
ODM-201
Other name:
ODM201
Intervention type:
Drug
Intervention name:
Leuprolide Acetate
Description:
Given IM
Arm group label:
Treatment (darolutamide, leuprolide acetate)
Other name:
A 43818
Other name:
A-43818
Other name:
A43818
Other name:
Abbott 43818
Other name:
Abbott-43818
Other name:
Carcinil
Other name:
Depo-Eligard
Other name:
Eligard
Other name:
Enanton
Other name:
Enantone
Other name:
Enantone-Gyn
Other name:
Fensolvi
Other name:
Ginecrin
Other name:
LEUP
Other name:
Leuplin
Other name:
Leuprorelin Acetate
Other name:
Lucrin
Other name:
Lucrin Depot
Other name:
Luprodex Depot
Other name:
Lupron
Other name:
Lupron Depot
Other name:
Lupron Depot-3 Month
Other name:
Lupron Depot-4 Month
Other name:
Lupron Depot-Ped
Other name:
Lutrate
Other name:
Procren
Other name:
Procrin
Other name:
Prostap
Other name:
TAP 144
Other name:
TAP-144
Other name:
TAP144
Other name:
Trenantone
Other name:
Uno-Enantone
Other name:
Viadur
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (darolutamide, leuprolide acetate)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Summary:
This phase II trial tests how well darolutamide and leuprolide acetate work in treating
patients with androgen receptor positive salivary cancer that has spread from where it
first started (primary site) to other places in the body (metastatic), cannot be removed
by surgery (unresectable) or that has come back after a period of responding to prior
therapy (recurrent). Darolutamide is in a class of medications called androgen receptor
inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to
stop the growth and spread of cancer cells. Leuprolide acetate is in a class of
medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing
the amount of certain hormones in the body. Giving darolutamide in combination with
leuprolide acetate may help to stop the growth of tumor cells that need androgens to grow
or shrink them.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the best overall response rate (BOR) of recurrent/metastatic androgen
receptor positive (AR+) salivary gland cancer (SGC) patients within one year of
darolutamide and androgen deprivation therapy (ADT).
SECONDARY OBJECTIVES:
I. To evaluate progression-free survival (PFS). II. To evaluate overall survival (OS).
III. To evaluate toxicity by Common Terminology Criteria for Adverse Events (CTCAE)
version (v) 5.0.
EXPLORATORY OBJECTIVES:
I. To evaluate molecular, genomic and transcriptomic biomarkers in serial research
biopsies obtained before and on darolutamide and ADT.
II. To evaluate the differences in BOR, PFS, OS with darolutamide and ADT treatment among
patients who did and did not receive prior systemic therapy for AR+ SGC.
OUTLINE:
Patients receive darolutamide orally (PO) twice daily (BID) on days 1-28 of each cycle
and leuprolide acetate intramuscularly (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 computed tomography (CT)/magnetic
resonance imaging (MRI) throughout the trial.
After completion of study treatment, patients are followed every 3-6 months for 2 years
after treatment discontinuation or until death, whichever occurs first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed salivary gland cancer
that is recurrent/metastatic or unresectable/locally advanced, with AR expression
detected by immunohistochemistry (IHC) on a Clinical Laboratory Improvement Act
(CLIA)-approved assay. Androgen receptor testing by immunohistochemistry (IHC) can
be performed locally in a CLIA (Clinical Laboratory Improvement Amendments)
certified lab
- Patients must have measurable disease
- Patients must have not had prior AR-targeted therapy, except for AR-targeted therapy
administered in the neoadjuvant and/or adjuvant setting and with disease recurrence
more than 6 months since treatment completion
- Age >= 18 years. Because no dosing or adverse event data are currently available on
the use of darolutamide in combination with leuprolide acetate in patients < 18
years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Absolute neutrophil count >= 1,000/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (exception:
patients with elevated bilirubin due to Gilbert's disease would be eligible for the
trial)
- Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase ([SGPT])
=< 3 x institutional ULN
- Creatinine =< 1.5 x institutional ULN
- Glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 (by Chronic Kidney Disease
Epidemiology Collaboration [CKD-EPI])
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
- Patients with treated brain metastases are eligible
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better
- The effects of darolutamide on the developing human fetus are unknown. For this
reason and because androgen receptor inhibitor agents as well as other therapeutic
agents used in this trial are known to be teratogenic (leuprolide-acetate), women of
child-bearing potential and men must agree to use adequate contraception
(non-hormonal or barrier method of birth control; abstinence) prior to study entry
and for the duration of study participation. Should a woman become pregnant or
suspect she is pregnant while she or her partner is participating in this study, she
should inform her treating physician immediately. Men and women treated or enrolled
on this protocol must also agree to use adequate contraception prior to the study,
for the duration of study participation, and 7 days after completion of darolutamide
administration or after the depot interval for the leuprolide-acetate dose used has
been completed, whichever is longer
- Ability to understand and the willingness to sign a written informed consent
document
- Patients must have tumors that are safely accessible for biopsy.
- Note: Two research biopsies are mandated in this trial. If the biopsy is deemed
to be unsafe after attempting the first biopsy, the patient will remain
eligible for the trial and subsequent tumor biopsies will not be required
Exclusion Criteria:
- Patients who have not recovered from adverse events due to prior anti-cancer therapy
(i.e., have residual toxicities > grade 1) with the exception of alopecia and
peripheral neuropathy
- Patients with a vascular or ischemic event within 6 months of study registration
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to darolutamide or leuprolide acetate
- Patients on combined P-gp and strong or moderate CYP3A inducers or BCRP substrates
are excluded. Because the lists of these agents are constantly changing, it is
important to regularly consult a frequently-updated medical reference. As part of
the enrollment/informed consent procedures, the patient will be counseled on the
risk of interactions with other agents, and what to do if new medications need to be
prescribed or if the patient is considering a new over-the-counter medicine or
herbal product
- Patients with uncontrolled intercurrent illness
- Pregnant women are excluded from this study because darolutamide is an androgen
receptor inhibitor agent with the potential for teratogenic or abortifacient
effects. Because there is an unknown but potential risk for adverse events in
nursing infants secondary to treatment of the mother with darolutamide and
leuprolide-acetate, breastfeeding should be discontinued if the mother is treated
with darolutamide and leuprolide-acetate. These potential risks may also apply to
other agents used in this study.
- Patients with moderate hepatic impairment (Child-Pugh Class B or C)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Address:
City:
Irvine
Zip:
92612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Shirin Attarian
Email:
Principal Investigator
Facility:
Name:
Los Angeles General Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Email:
uscnorrisinfo@med.usc.edu
Investigator:
Last name:
Jacob S. Thomas
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
323-865-0451
Investigator:
Last name:
Jacob S. Thomas
Email:
Principal Investigator
Facility:
Name:
UC Irvine Health/Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Shirin Attarian
Email:
Principal Investigator
Facility:
Name:
UCHealth University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Suspended
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-946-7447
Investigator:
Last name:
Conor E. Steuer
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Alan L. Ho
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Alan L. Ho
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Alan L. Ho
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Alan L. Ho
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Alan L. Ho
Email:
Principal Investigator
Facility:
Name:
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
CancerTrials@nyulangone.org
Investigator:
Last name:
Zujun Li
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Alan L. Ho
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
212-639-7592
Investigator:
Last name:
Alan L. Ho
Email:
Principal Investigator
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-668-0683
Email:
cancerclinicaltrials@med.unc.edu
Investigator:
Last name:
Shetal Patel
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Minh Phan
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh Cancer Institute (UPCI)
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-647-8073
Investigator:
Last name:
Dan P. Zandberg
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-632-6789
Email:
askmdanderson@mdanderson.org
Investigator:
Last name:
Renata Ferrarotto
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-424-2100
Email:
cancerinfo@hci.utah.edu
Investigator:
Last name:
Kathleen C. Kerrigan
Email:
Principal Investigator
Facility:
Name:
University of Virginia Cancer Center
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
434-243-6303
Email:
uvacancertrials@hscmail.mcc.virginia.edu
Investigator:
Last name:
Varinder Kaur
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Address:
City:
Madison
Zip:
53718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-622-8922
Email:
clinicaltrials@cancer.wisc.edu
Investigator:
Last name:
Justine Yang-Bruce
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin Carbone Cancer Center - University Hospital
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-622-8922
Email:
clinicaltrials@cancer.wisc.edu
Investigator:
Last name:
Justine Yang-Bruce
Email:
Principal Investigator
Start date:
July 20, 2023
Completion date:
April 11, 2027
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05669664
