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Trial of ARV-110 and Abiraterone 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: NCT05177042
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Arvinas Inc. ( Arvinas Androgen Receptor, Inc. )

Brief Summary:
Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with PSA progression on abiraterone.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Abiraterone

Arm Intervention/treatment
Experimental: Oral tablet(s) in combination with abiraterone and a corticosteroid.
ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles.
Drug: ARV-110 in Combination with Abiraterone
ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities of ARV-110 in combination with abiraterone [ Time Frame: 4 weeks ]
    Dose limiting toxicities in first 4 weeks of the study combination treatment characterized by type, frequency, severity (as graded by NCI CTCAE v 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 in combination with abiraterone [ Time Frame: 35 days after subject discontinues study treatment ]
    Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination

  3. Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110 in combination with abiraterone [ Time Frame: 35 days after subject discontinues study treatment ]
    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.

  4. Recommended Phase 2 dose (RP2D)/schedule for the combination [ Time Frame: 4 weeks ]
    Dose limiting toxicities in first 4 weeks of the study combination treatment will be assessed to determine the dose of ARV-110 and abiraterone associated with acceptable safety and tolerability.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
  2. Ongoing treatment with stable doses of abiraterone and a concomitant corticosteroid for metastatic castration-resistant prostate cancer (CRPC) or for castration sensitive prostate cancer CSPC until Cycle 1, Day 1 (C1D1).
  3. Recent PSA values prior to signing consent must demonstrate:

    1. PSA progression no less than 16 weeks after initiation of abiraterone
    2. A sequence of at least 2 rising PSA values measured at a minimum of 1 week apart (if PSA is <2 ng/ml, a sequence of at least 3 rising PSA values measured a minimum of 1 week apart is required)
  4. No known radiographic evidence of disease progression while receiving abiraterone (prior to signing consent for this study).
  5. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (surgical or medical castration).
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  1. Previously treated with enzalutamide, apalutamide, darolutamide or experimental therapies (e.g., protein degraders or inhibitors) directed at the AR.
  2. Treatment with any chemotherapy, investigational agents, immunotherapy, or hormonal therapy other than GnRH agonists within 28 days of the start of treatment on protocol.
  3. Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow.
  4. Patients taking agents that are P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) substrates, CYP3A4 substrate, CYP2D6 substrate that have a narrow therapeutic index, strong CYP3A4 inhibitors or inducers.
  5. Major surgery (as judged by the Investigator) within 4 weeks of first dose of study drug.
  6. Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class II, III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant episode of thromboembolic disease.
  7. Any of the following in the previous 6 months: congenital long QT syndrome, Torsade de Pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), left anterior hemiblock (bifascicular block), or ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥2, atrial fibrillation of any grade (Grade ≥2 in the case of asymptomatic lone atrial fibrillation). Anticoagulation (heparin/lovenox only, no vitamin K antagonists or factor Xa inhibitors) can be allowed if indicated.
  8. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
  9. Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness.
  10. Active inflammatory gastrointestinal disease, uncontrolled chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
  11. Patients with Child Pugh C.

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): NCT05177042


Contacts
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Contact: Arvinas Androgen Receptor, Inc. 475-345-3354 clinicaltrialsARV-110@arvinas.com

Locations
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United States, California
Clinical Trial Site Recruiting
Santa Monica, California, United States, 91361
United States, Florida
Clinical Trial Site Not yet recruiting
Fort Myers, Florida, United States, 33916
Clinical Trial Site Recruiting
Tampa, Florida, United States, 33612
United States, Massachusetts
Clinical Trial Site Recruiting
Boston, Massachusetts, United States, 02114
United States, South Carolina
Clinical Trial Site Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Clinical Trial Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Virginia
Clinical Trial Site Recruiting
Charlottesville, Virginia, United States, 22903
Canada, British Columbia
Clinical Trial Site Not yet recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Clinical Trial Site Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Clinical Trial Site Not yet recruiting
Montreal, Quebec, Canada
France
Clinical Trial Site Not yet recruiting
Caen, France
Clinical Trial Site Not yet recruiting
Paris, France
Clinical Trial Site Not yet recruiting
Villejuif, France
United Kingdom
Clinical Trial Site Not yet recruiting
London, England, United Kingdom
Clinical Trial Site Not yet recruiting
Preston, England, United Kingdom
Clinical Trial Site Not yet recruiting
Wirral, England, United Kingdom
Clinical Trial Site Not yet recruiting
Cardiff, Wales, United Kingdom
Sponsors and Collaborators
Arvinas Androgen Receptor, Inc.
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Responsible Party: Arvinas Androgen Receptor, Inc.
ClinicalTrials.gov Identifier: NCT05177042    
Other Study ID Numbers: ARV-110-mCRPC-103
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arvinas Inc. ( Arvinas Androgen Receptor, Inc. ):
Metastatic Prostate Cancer
Prostate Cancer
Castrate-Resistant
mCRPC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases