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

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ClinicalTrials.gov Identifier: NCT03888612
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Arvinas Inc

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • Incidence of Dose Limiting Toxicities of ARV-110 [ Time Frame: 28 Days ]
    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
  • Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110 [ Time Frame: 28 Days ]
    Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
  • Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110 [ Time Frame: 28 Days ]
    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • Safety and Tolerability of ARV-110 [ Time Frame: 28 Days ]
    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
  • Safety and Tolerability of ARV-110 [ Time Frame: 28 Days ]
    First cycle adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
  • Safety and Tolerability of ARV-110 [ Time Frame: 28 Days ]
    First cycle laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Change History Complete list of historical versions of study NCT03888612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Clinical Trial of ARV-110 in Patients With Metastatic Castration-resistant Prostate Cancer.
Official Title  ICMJE 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.
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer Metastatic
Intervention  ICMJE Drug: ARV-110
Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment
Study Arms  ICMJE Experimental: ARV-110
oral tablet(s), once daily with food in 28 day cycles
Intervention: Drug: ARV-110
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Garfield 475-234-5736 Mary.Garfield@arvinas.com
Contact: Jennifer Ranciato 475-234-5700 Jennifer.Ranciato@arvinas.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03888612
Other Study ID Numbers  ICMJE ARV-110-mCRPC-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arvinas Inc
Study Sponsor  ICMJE Arvinas Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arvinas Inc
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP