A Phase 2 interventional study of Abivertinib and Abiraterone in Prostate Cancer and Prostate Cancer Metastatic, sponsored by Sorrento Therapeutics, Inc.. Suspended at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Sorrento Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sorrento Therapeutics, Inc. is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Abiraterone-naive: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
Drug: Abivertinib · Drug: Abiraterone
Abiraterone-progressing: Abivertinib 200 mg by mouth twice daily with abiraterone 1000 mg by mouth daily.
Drug: Abivertinib · Drug: Abiraterone
Abivertinib is a small molecule inhibitor
Also known as: STI-5656
Hormone-based chemotherapy
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.
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
This study is suspended, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Sorrento Therapeutics, Inc.