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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 : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Arvinas Inc. ( Arvinas Androgen Receptor, Inc. )

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

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

Study Design
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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 : November 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

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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 (on an empty stomach) and a concomitant corticosteroid for metastatic castration-resistant prostate cancer (mCRPC) or for metastatic castration sensitive prostate cancer (mCSPC) until Cycle 1, Day 1 (C1D1).

  3. Recent PSA values must demonstrate:

    1. Rising PSAs at least 16 weeks after initiation of abiraterone
    2. At least 2 PSA values that are higher than the PSA nadir on abiraterone, measured at a minimum of 1 week apart . The screening PSA for this study may be used as the 2nd PSA value.
  4. No known radiographic evidence of disease progression while receiving abiraterone and clinically benefitting at the time of consent. If there is radiographic disease progression during screening, the patient may be considered eligible if, in the judgement of the investigator, the patient is clinically benefitting from abiraterone.
  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 either a) sensitive P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) substrates, or CYP3A4 substrates, b) P-gp, BCRP, CYP3A4, or CYP2D6 substrates that have a narrow therapeutic index, c) strong CYP3A4 inhibitors or inducers, or d) any other prohibited and/or restricted medications described in the protocol.
  5. Major surgery (as judged by the Investigator) within 4 weeks of first dose of study drug.
  6. Untreated brain metastases or brain metastases requiring steroids
  7. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  8. 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.
  9. 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)..
  10. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
  11. 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.
  12. Active inflammatory gastrointestinal disease, uncontrolled chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery. Gastroesophageal reflux disease is allowed except for if under treatment with proton pump inhibitors.
  13. Patients with Child Pugh C.
  14. Patients with electrolyte imbalances of hypokalemia, hypomagnesemia, and/or hypocalcemia.
  15. Patients with QTcF ≥470 msec.
Contacts and Locations
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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 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, Ohio
Clinical Trial Site Recruiting
Columbus, Ohio, United States, 43210
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 Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Clinical Trial Site Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Clinical Trial Site Recruiting
Montreal, Quebec, Canada
France
Clinical Trial Site Recruiting
Caen, France
Clinical Trial Site Recruiting
Paris, France
Clinical Trial Site Recruiting
Villejuif, France
United Kingdom
Clinical Trial Site Recruiting
London, England, United Kingdom
Clinical Trial Site Not yet recruiting
Cardiff, Wales, United Kingdom
Sponsors and Collaborators
Arvinas Androgen Receptor, Inc.
More Information
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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: March 10, 2023
Last Verified: March 2023

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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
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases