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

NCT03888612

Description:

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).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Clinical Trial of ARV-110 in Patients With Metastatic Castration-resistant Prostate Cancer.
  • Official Title: 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.

Clinical Trial IDs

  • ORG STUDY ID: ARV-110-mCRPC-101
  • NCT ID: NCT03888612

Conditions

  • Prostate Cancer Metastatic

Interventions

DrugSynonymsArms
ARV-110ARV-110

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
ARV-110Experimentaloral tablet(s), once daily with food in 28 day cycles
  • ARV-110

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Dose Limiting Toxicities of ARV-110
Time Frame:28 Days
Safety Issue:
Description:First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arvinas Inc

Trial Keywords

  • Metastatic Prostate Cancer
  • Castrate-Resistant
  • Prostate Cancer
  • mCRPC
  • adenocarcinoma of the prostate

Last Updated

June 4, 2019