Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer
Completed · Phase 1/Phase 2
Conditions studied: Prostate Cancer Metastatic
In brief
Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).
Key facts
- Study ID
- NCT03888612
- Run by
- Arvinas Inc.
- People needed
- 248
- Starts
- 2019-03-01
- Expected to finish
- 2025-01-27
- Last updated by the study team
- 2025-04-01
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Part A:
- 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).
- Part B:
- 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 received at least one but no more than two prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone) for CRPC.
- Patients must have received no more than one prior chemotherapy regimen in each of the following settings: castrate sensitive and castrate resistant prostate cancer.
- Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
- Part B - Phase 2 Expansion Cohort Subgroup 4
- Patient has received only one prior AR second generation therapy (e.g., abiraterone or enzalutamide) either as treatment for CSPC or CRPC and no more than 1 regimen in CRPC setting.
- No prior chemotherapy
You may not qualify if…
- Part A:
- 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.
- Part B:
- 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.
Where it is running
- Clinical Trial Site — Orange, California, United States
- Clinical Trial Site — San Francisco, California, United States
- Clinical Trial Site — New Haven, Connecticut, United States
- Clinical Trial Site — Altamonte Springs, Florida, United States
- Clinical Trial Site — Bonita Springs, Florida, United States
- Clinical Trial Site — Bradenton, Florida, United States
- Clinical Trial Site — Brandon, Florida, United States
- Clinical Trial Site — Cape Coral, Florida, United States
- Clinical Trial Site — Clearwater, Florida, United States
- Clinical Trial Site — Daytona Beach, Florida, United States
- Clinical Trial Site — Fleming Island, Florida, United States
- Clinical Trial Site — Fort Myers, Florida, United States
- Clinical Trial Site — Gainesville, Florida, United States
- Clinical Trial Site — Largo, Florida, United States
- Clinical Trial Site — Lecanto, Florida, United States
- Clinical Trial Site — Naples, Florida, United States
- Clinical Trial Site — New Port Richey, Florida, United States
- Clinical Trial Site — Ocala, Florida, United States
- Clinical Trial Site — Orange City, Florida, United States
- Clinical Trial Site — Orlando, Florida, United States
- Clinical Trial Site — Port Charlotte, Florida, United States
- Clinical Trial Site — Sarasota, Florida, United States
- Clinical Trial Site — Spring Hill, Florida, United States
- Clinical Trial Site — St. Petersburg, Florida, United States
- Clinical Trial Site — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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