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
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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 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 |
Arm | Intervention/treatment |
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Experimental: ARV-766
Oral tablets, once daily in 28 day cycles
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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 |
- 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
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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
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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 |
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
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
Contact: Arvinas Androgen Receptor, Inc. | 475-345-3374 | clinicaltrialsARV-766@arvinas.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Metastatic Prostate Cancer Castrate-Resistant Prostate Cancer mCRPC adenocarcinoma of prostate Prostatic Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Castrate-Sensitive mCSPC adenocarcinoma of prostate |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |