Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03888612
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Arvinas Inc

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: ARV-110 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888612


Contacts
Layout table for location contacts
Contact: Mary Garfield 475-234-5736 Mary.Garfield@arvinas.com
Contact: Jennifer Ranciato 475-234-5700 Jennifer.Ranciato@arvinas.com

Locations
Layout table for location information
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Massachusetts General Hospital 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
Sponsors and Collaborators
Arvinas Inc

Layout table for additonal information
Responsible Party: Arvinas Inc
ClinicalTrials.gov Identifier: NCT03888612     History of Changes
Other Study ID Numbers: ARV-110-mCRPC-101
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arvinas Inc:
Metastatic Prostate Cancer
Castrate-Resistant
Prostate Cancer
mCRPC
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases