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Clinical Trial Finder

Search Results

A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Male
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05067140
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arvinas Androgen Receptor, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Prostate Cancer Metastatic
Arms & Interventions

Arms

Experimental: ARV-766

Oral tablets, once daily in 28 day cycles

Experimental: ARV-766 + Abiraterone

Oral tablets, once daily in 28 day cycles

Interventions

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.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Trial Site, Duarte, California

Status

Recruiting

Address

Clinical Trial Site

Duarte, California, 91010

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Fresno, California

Status

Recruiting

Address

Clinical Trial Site

Fresno, California, 93720

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, La Jolla, California

Status

Recruiting

Address

Clinical Trial Site

La Jolla, California, 92037

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Orange, California

Status

Recruiting

Address

Clinical Trial Site

Orange, California, 92868

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Santa Monica, California

Status

Recruiting

Address

Clinical Trial Site

Santa Monica, California, 90404

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, New Haven, Connecticut

Status

Recruiting

Address

Clinical Trial Site

New Haven, Connecticut, 06510

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Washington, District of Columbia

Status

Not yet recruiting

Address

Clinical Trial Site

Washington, District of Columbia, 20007

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Lake Mary, Florida

Status

Recruiting

Address

Clinical Trial Site

Lake Mary, Florida, 32746

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Chicago, Illinois

Status

Recruiting

Address

Clinical Trial Site

Chicago, Illinois, 60611

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, New Orleans, Louisiana

Status

Recruiting

Address

Clinical Trial Site

New Orleans, Louisiana, 70112

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Baltimore, Maryland

Status

Recruiting

Address

Clinical Trial Site

Baltimore, Maryland, 21204

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Boston, Massachusetts

Status

Recruiting

Address

Clinical Trial Site

Boston, Massachusetts, 02114

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Detroit, Michigan

Status

Recruiting

Address

Clinical Trial Site

Detroit, Michigan, 48201

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Buffalo, New York

Status

Recruiting

Address

Clinical Trial Site

Buffalo, New York, 14203

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, New York, New York

Status

Recruiting

Address

Clinical Trial Site

New York, New York, 10065

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Clinical Trial Site

Philadelphia, Pennsylvania, 19144

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Clinical Trial Site

Pittsburgh, Pennsylvania, 15232

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Myrtle Beach, South Carolina

Status

Recruiting

Address

Clinical Trial Site

Myrtle Beach, South Carolina, 29572

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Nashville, Tennessee

Status

Recruiting

Address

Clinical Trial Site

Nashville, Tennessee, 37203

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, San Antonio, Texas

Status

Recruiting

Address

Clinical Trial Site

San Antonio, Texas, 78229

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Charlottesville, Virginia

Status

Recruiting

Address

Clinical Trial Site

Charlottesville, Virginia, 22908

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Fairfax, Virginia

Status

Recruiting

Address

Clinical Trial Site

Fairfax, Virginia, 22031

Site Contact

[email protected]

475-345-3374

Clinical Trial Site, Madison, Wisconsin

Status

Recruiting

Address

Clinical Trial Site

Madison, Wisconsin, 53705

Site Contact

[email protected]

475-345-3374

Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with a healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with site contacts or other relevant parties. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage trial participants to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

The THANC Foundation is a 501(c)(3) charitable organization.

Federal Tax ID 80-0062118.

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THANC’s Mission

We are committed to supporting research and education in the early detection and treatment of thyroid and head and neck cancer; to advancing new therapeutic approaches; and to alleviating the suffering and functional impairment of patients who undergo treatment.

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