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Trial record 1 of 3 for:    Arvinas Prostate
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A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT05067140
Recruitment Status : Recruiting
First Posted : October 5, 2021
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Arvinas Inc. ( Arvinas Androgen Receptor, Inc. )

Study Description
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Brief Summary:
A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: ARV-766 Part A&B Drug: ARV-766 + Abiraterone Part C&D Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
Actual Study Start Date : September 2, 2021
Estimated Primary Completion Date : December 6, 2025
Estimated Study Completion Date : June 27, 2026

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: ARV-766
Oral tablets, once daily in 28 day cycles
 Drug: ARV-766 Part A&B

Part A: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

Part B: Oral tablet(s) once daily in 28 day cycles.
Experimental: ARV-766 + Abiraterone
Oral tablets, once daily in 28 day cycles
 Drug: ARV-766 + Abiraterone Part C&D

Part C: Daily oral combination dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.

Part D: Combination administered once daily in 28 day cycles.

Parts C&D: Participants will also receive concomitant corticosteroid and ADT therapy of investigator choice/patient preference

Other Name: Corticosteroid and ADT


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Incidence of Dose Limiting Toxicities of ARV-766 [ Time Frame: 28 Days ]
    First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug

  2. Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 [ Time Frame: 28 Days ]
    Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.

  3. Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 [ Time Frame: 28 Days ]
    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.

  4. Part B: To evaluate the clinical anti-tumor activity of ARV-766 in patients with mCRPC [ Time Frame: 12 Weeks ]
    Evaluate PSA in patients with mCRPC in both dose groups

  5. Part C: Incidence of Dose Limiting Toxicities of ARV-766 / abiraterone combination [ Time Frame: 28 Days ]
    First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug

  6. Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-766 / abiraterone combination [ Time Frame: 28 Days ]
    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.

  7. Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-766 / abiraterone combination [ Time Frame: 28 Days ]
    Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.

  8. Part D: To evaluate the clinical anti-tumor activity of ARV-766 / abiraterone combination in patients with NHA-naïve mPC [ Time Frame: 12 Weeks ]
    Evaluate PSA in patients with NHA-naïve mPC


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

Inclusion Criteria:

Part A,B,C and D:

  • Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Part A:

  • Progression on at least 2 prior approved systemic therapies for metastatic prostate cancer (at least one must be a second-generation androgen inhibitor, e.g., abiraterone, enzalutamide, darolutamide, apalutamide).
  • Progressive mCRPC

Part B:

  • Participants must have received at least one but no more than three prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone).
  • Participants must have received no more than two prior chemotherapy regimens.
  • Progressive mCRPC

Part C & D:

• Metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease

Exclusion Criteria:

Part A and B:

  • Known symptomatic brain metastases requiring steroids (above physiologic replacement doses).
  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery.
  • Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow.
  • Receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose
  • Systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). For bicalutamide, mitomycin C, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks.

Part C and D

• Prior treatment with a second generation NHA

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): NCT05067140


Contacts
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Contact: Arvinas Androgen Receptor, Inc. 475-345-3374 clinicaltrialsARV-766@arvinas.com

Locations
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United States, California
Clinical Trial Site Recruiting
Duarte, California, United States, 91010
Clinical Trial Site Recruiting
Fresno, California, United States, 93720
Clinical Trial Site Recruiting
La Jolla, California, United States, 92037
Clinical Trial Site Recruiting
Orange, California, United States, 92868
Clinical Trial Site Recruiting
Santa Monica, California, United States, 90404
United States, Connecticut
Clinical Trial Site Recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Clinical Trial Site Not yet recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Clinical Trial Site Recruiting
Lake Mary, Florida, United States, 32746
United States, Illinois
Clinical Trial Site Recruiting
Chicago, Illinois, United States, 60611
United States, Louisiana
Clinical Trial Site Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Clinical Trial Site Recruiting
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Clinical Trial Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Clinical Trial Site Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Clinical Trial Site Recruiting
Buffalo, New York, United States, 14203
Clinical Trial Site Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Clinical Trial Site Recruiting
Philadelphia, Pennsylvania, United States, 19144
Clinical Trial Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
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, Texas
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Clinical Trial Site Recruiting
Charlottesville, Virginia, United States, 22908
Clinical Trial Site Recruiting
Fairfax, Virginia, United States, 22031
United States, Wisconsin
Clinical Trial Site Recruiting
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Arvinas Androgen Receptor, Inc.
More Information
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Responsible Party: Arvinas Androgen Receptor, Inc.
ClinicalTrials.gov Identifier: NCT05067140    
Other Study ID Numbers: ARV-766-mCRPC-101
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024

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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
Castrate-Resistant
Prostate Cancer
mCRPC adenocarcinoma of prostate
Prostatic Neoplasms
 Genital Neoplasms, Male
Urogenital Neoplasms
Castrate-Sensitive
mCSPC adenocarcinoma of prostate
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