Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    150
  • sponsor
    Arvinas Inc
Updated on 2 July 2021
gonadotropin
abiraterone
orchiectomy
enzalutamide
castration-resistant prostate cancer
medical castration
adenocarcinoma
metastatic castration-resistant prostate cancer

Summary

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).

Details
Condition Metastatic Prostate Cancer, Prostate Cancer Metastatic
Treatment ARV-110
Clinical Study IdentifierNCT03888612
SponsorArvinas Inc
Last Modified on2 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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