Trial of ARV-110 and Abiraterone in Patients with Metastatic Castration Resistant Prostate Cancer
Research type
Research Study
Full 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
IRAS ID
1004437
Contact name
Debbie Chirnomas
Contact email
Sponsor organisation
Arvinas Androgen Receptor, Inc.
Eudract number
2021-003046-21
Clinicaltrials.gov Identifier
Research summary
Arvinas Androgen Receptor, Inc. (the Sponsor) is running a Phase 1b, open-label research study to evaluate the safety and tolerability of the test drug ARV-110 in combination with abiraterone, and select the recommended Phase 2 dose (RP2D)/schedule for the combination in patients with metastatic prostate cancer.
Despite some available therapies, there is still a need for new treatments to target metastatic prostate cancer. Abiraterone is currently approved by the MHRA for the treatment of metastatic prostate cancer. However, approximately 10-33% of patients are expected to develop resistance to Abiraterone, leading to disease progression. Combining Abiraterone with another medication, such as ARV-110, may overcome this resistance and restore appropriate Abiraterone function.
The study is planned to involve approximately 40 participants who have metastatic prostate cancer, who are currently receiving Abiraterone and have prostate-specific antigen (PSA) progression on abiraterone. An initial screening phase will check eligibility for the study. The first part of the study is to determine the dose of both ARV-110 and Abiraterone when taken together. The starting dose of ARV-110 will be 420 mg daily, taken by mouth. The dose of Abiraterone will be either 1000 mg daily, or the same dose received immediately before starting the study, along with a corticosteroid. Other doses may also be tested. Once a dose level of both medications is determined, then these doses will be given to a larger number of participants in the second part of the study. It is expected that treatment may last a minimum of 28 days and participation will involve a minimum of 7 visits to the study site.
Study assessments include: vital signs, collecting blood, urinalysis, electrocardiogram, physical examination, CT scans or MRI scans, Bone Nuclear Medicine scans and possible tumour biopsy.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0042
Date of REC Opinion
28 Mar 2022
REC opinion
Further Information Favourable Opinion