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 |
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).
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
9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
Click here to add this to my saved trials
Click here to add this to my saved trials
3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
Click here to add this to my saved trials
Click here to add this to my saved trials