This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer.
This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer via assessment of 6-month radiographic progression-free survival. The study will include two cohorts, abiraterone-naive and abiraterone-progressing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Abivertinib is a small molecule inhibitor
Hormone-based chemotherapy
UCSD Moores Cancer Center
La Jolla, California, United States
Cleveland Clinic
Cleveland, Ohio, United States
6-month radiographic progression-free survival
6-month radiographic progression-free survival (rPFS) will be assessed as defined by percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases.
Time frame: baseline through study completion at up to approximately 63 months
Overall Response Rate
Overall Response Rate (ORR) will be defined by percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: baseline through study completion at up to approximately 63 months
Duration of response
duration of response will be defined as the time from the first documented response in patients with measurable disease to the date of progression or death due to any cause.
Time frame: baseline through study completion at up to approximately 63 months
Prostate-Specific Antigen (PSA) progression
Change in PSA as compared to baseline as defined by Prostate Cancer Working Group 3 (PCWG3) criteria
Time frame: baseline through study completion at up to approximately 63 months
Safety and tolerability
Safety and tolerability of abivertinib with abiraterone using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria.
Time frame: baseline through study completion at up to approximately 63 months
Time to occurrence of first skeletal event
Time to occurrence of first symptomatic skeletal event will be defined as the time from enrollment to the first symptomatic skeletal event defined as use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumor related orthopedic surgical intervention.
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Time frame: baseline through study completion at up to approximately 63 months
Time to first subsequent anti-cancer therapy
Time to first subsequent anti-cancer therapy will be defined as the time from treatment discontinuation for any reason to start of subsequent anti-cancer therapy or death.
Time frame: baseline through study completion at up to approximately 63 months
6-month radiographic progression-free survival (rPFS)
6-month radiographic progression-free survival (rPFS) will be defined as the time from enrollment to progression by by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases or death, whichever occurs first.
Time frame: baseline through study completion at up to approximately 63 months
Overall survival
Overall survival will be defined as the time from enrollment to death
Time frame: baseline through study completion at up to approximately 63 months