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History of Changes for Study: NCT03888612
A Phase 1 Clinical Trial of ARV-110 in Patients With Metastatic Castration-resistant Prostate Cancer. (mCRPC)
Latest version (submitted November 12, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 22, 2019 None (earliest Version on record)
2 March 22, 2019 Outcome Measures and Study Status
3 April 4, 2019 Contacts/Locations and Study Status
4 May 10, 2019 Study Status and Contacts/Locations
5 June 4, 2019 Study Status and Contacts/Locations
6 September 16, 2020 Contacts/Locations, Study Status, Outcome Measures, Arms and Interventions, Study Design, Study Identification, Eligibility and Study Description
7 January 29, 2021 Contacts/Locations and Study Status
8 June 23, 2021 Contacts/Locations and Study Status
9 November 12, 2021 Contacts/Locations, Outcome Measures, Study Status, Sponsor/Collaborators and Study Design
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Study NCT03888612
Submitted Date:  March 22, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: ARV-110-mCRPC-101
Brief Title: A Phase 1 Clinical Trial of ARV-110 in Patients With Metastatic Castration-resistant Prostate Cancer. (mCRPC)
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2019
Overall Status: Recruiting
Study Start: March 1, 2019
Primary Completion: March 31, 2021 [Anticipated]
Study Completion: December 31, 2021 [Anticipated]
First Submitted: March 21, 2019
First Submitted that
Met QC Criteria:
March 22, 2019
First Posted: March 25, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
March 22, 2019
Last Update Posted: March 25, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Arvinas Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Prostate Cancer Metastatic
Keywords: Metastatic Prostate Cancer
Castrate-Resistant
Prostate Cancer
mCRPC
adenocarcinoma of the prostate
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ARV-110
oral tablet(s), once daily with food in 28 day cycles
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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.
3. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Natalie Sakarakis
Telephone: 919-376-6633
Email: Natalie.Sacarakis@iqvia.com
Locations: United States, Connecticut
Yale School of Medicine
[Not yet recruiting]
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Massachusetts General Hospital
[Not yet recruiting]
Boston, Massachusetts, United States, 02114
United States, Nevada
Comprehensive Cancer Centers of Nevada
[Recruiting]
Las Vegas, Nevada, United States, 89169
United States, Tennessee
Sarah Cannon Research Institute
[Recruiting]
Nashville, Tennessee, United States, 37203
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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