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Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Sponsor
Arvinas Androgen Receptor, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05177042
Collaborator
(none)
40
Enrollment
17
Locations
1
Arm
21
Anticipated Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with PSA progression on abiraterone.

Condition or Disease Intervention/Treatment Phase
  • Drug: ARV-110 in Combination with Abiraterone
 Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Incidence of dose limiting toxicities of ARV-110 in combination with abiraterone [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate.

  2. Ongoing treatment with stable doses of abiraterone and a concomitant corticosteroid for metastatic castration-resistant prostate cancer (CRPC) or for castration sensitive prostate cancer CSPC until Cycle 1, Day 1 (C1D1).

  3. Recent PSA values prior to signing consent must demonstrate:

  4. PSA progression no less than 16 weeks after initiation of abiraterone

  5. A sequence of at least 2 rising PSA values measured at a minimum of 1 week apart (if PSA is <2 ng/ml, a sequence of at least 3 rising PSA values measured a minimum of 1 week apart is required)

  6. No known radiographic evidence of disease progression while receiving abiraterone (prior to signing consent for this study).

  7. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (surgical or medical castration).

  8. 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.

  1. Patients taking agents that are P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) substrates, CYP3A4 substrate, CYP2D6 substrate that have a narrow therapeutic index, strong CYP3A4 inhibitors or inducers.

  2. Major surgery (as judged by the Investigator) within 4 weeks of first dose of study drug.

  3. 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.

  4. 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). Anticoagulation (heparin/lovenox only, no vitamin K antagonists or factor Xa inhibitors) can be allowed if indicated.

  5. Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).

  6. 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.

  7. Active inflammatory gastrointestinal disease, uncontrolled chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.

  8. Patients with Child Pugh C.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Trial Site Santa Monica California United States 91361
2 Clinical Trial Site Fort Myers Florida United States 33916
3 Clinical Trial Site Tampa Florida United States 33612
4 Clinical Trial Site Boston Massachusetts United States 02114
5 Clinical Trial Site Myrtle Beach South Carolina United States 29572
6 Clinical Trial Site Nashville Tennessee United States 37203
7 Clinical Trial Site Charlottesville Virginia United States 22903
8 Clinical Trial Site Vancouver British Columbia Canada
9 Clinical Trial Site Toronto Ontario Canada
10 Clinical Trial Site Montreal Quebec Canada
11 Clinical Trial Site Caen France
12 Clinical Trial Site Paris France
13 Clinical Trial Site Villejuif France
14 Clinical Trial Site London England United Kingdom
15 Clinical Trial Site Preston England United Kingdom
16 Clinical Trial Site Wirral England United Kingdom
17 Clinical Trial Site Cardiff Wales United Kingdom

Sponsors and Collaborators

  • Arvinas Androgen Receptor, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arvinas Androgen Receptor, Inc.
ClinicalTrials.gov Identifier:
NCT05177042
Other Study ID Numbers:
  • ARV-110-mCRPC-103
First Posted:
Jan 4, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arvinas Androgen Receptor, Inc.
Metastatic Prostate Cancer
Prostate Cancer
Castrate-Resistant
mCRPC
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 22, 2022