We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. )

Tracking Information
First Submitted Date  ICMJE November 19, 2021
First Posted Date  ICMJE January 4, 2022
Last Update Posted Date March 10, 2023
Actual Study Start Date  ICMJE February 1, 2022
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2021)
  • 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
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer Metastatic
Intervention  ICMJE Drug: ARV-110 in Combination with Abiraterone
ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles
Study Arms  ICMJE 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.
Intervention: Drug: ARV-110 in Combination with Abiraterone
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: December 15, 2021)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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: Arvinas Androgen Receptor, Inc. 475-345-3354 clinicaltrialsARV-110@arvinas.com
Listed Location Countries  ICMJE Canada,   France,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05177042
Other Study ID Numbers  ICMJE ARV-110-mCRPC-103
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 Not Provided
Current Responsible Party Arvinas Inc. ( Arvinas Androgen Receptor, Inc. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arvinas Androgen Receptor, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arvinas Inc.
Verification Date March 2023

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