A Phase 1 Clinical Trial of ARV-110 in Patients With Metastatic Castration-resistant Prostate Cancer.



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 1, 2019
End Date:December 31, 2021
Contact:Mary Garfield
Email:Mary.Garfield@arvinas.com
Phone:475-234-5736

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A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration-resistant Prostate Cancer Who Have Progressed on at Least Two Prior Systemic Therapies.

This is a first in human, dose escalation study and will assess the safety and tolerability
of ARV 110 in men with mCRPC who have progressed on at least 2 prior approved systemic
therapies for their castrate resistant disease (one of which must be enzalutamide or
abiraterone).


Inclusion Criteria:

- Patients must be male and at least 18 years of age at the time of signing the informed
consent.

- Patients must present with histological, pathological, or cytological confirmed
diagnosis of advanced or metastatic castration resistant adenocarcinoma of the
prostate.

- Patients must have progressed on at least 2 prior approved systemic therapies for CRPC
(at least one must be abiraterone or enzalutamide).

- Patients with progressive mCRPC

- Patients must have ongoing ADT with a gonadotropin releasing hormone analog or
inhibitor, or orchiectomy (surgical or medical castration).

Exclusion Criteria:

- Patients with known symptomatic brain metastases requiring steroids (above physiologic
replacement doses)

- Major surgery (as defined by the Investigator) within 4 weeks of first dose of study
drug.

- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to
>25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone
metastasis will be allowed during the study

- Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for
bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are
ineligible if they received any other type of anti cancer agent (except agents to
maintain castrate status) within 2 weeks before first dose of study drug.
We found this trial at
4
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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New Haven, Connecticut 06520
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New Haven, CT
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