Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent (VERACITY)
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|ClinicalTrials.gov Identifier: NCT04844749|
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : September 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-resistant Prostate Cancer Androgen Resistant Prostatic Cancer||Drug: VERU-111 Drug: Enzalutamide, Abiraterone, Darolutamide and Apalutamide||Phase 3|
This study is a multicenter, randomized, open-label, active-control, efficacy and safety study of VERU-111 (Sabizabulin) for the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent.
Subjects will have failed treatment with at least one prior androgen receptor targeting agent and be eligible for treatment with an alternative androgen receptor targeting agent (as per the current standard of care for these patients).
Subjects will be randomized in a 2:1 ratio to receive VERU-111 or Active Control (alternative androgen receptor targeting agent).
Subjects in the VERU-111 treated group will receive VERU-111 32 mg per day orally with an option to reduce the dose to 26 mg per day based on tolerability to the 32 mg dose until radiographic progression (blinded independent central read) in observed. Subjects in the Control treated group will receive an alternative androgen receptor targeting agent with dose and dosing regimen defined in the FDA approved prescribing information until radiographic progression in observed.
Randomization will be stratified by measurable disease vs. bone-only disease. A significant proportion (>30%) of the patients randomized into the study will have measurable disease at baseline.
Randomization will also be stratified by if the patient has failed one vs. more than one prior androgen targeting agent.
The primary efficacy endpoint of the study will be radiographic progression free survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This randomized, open-label, active-control clinical study consists of two treatment arms:VERU-111 (Sabizabulin) treated group, and Control treated group. Subjects will be randomized in a 2:1 fashion.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Central reader for scans will be blinded|
|Official Title:||VERACITY - Randomized, Active-Controlled, Phase 3 Study of VERU-111 for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Who Have Failed Prior Treatment With at Least One Androgen Receptor Targeting Agent|
|Actual Study Start Date :||June 24, 2021|
|Estimated Primary Completion Date :||April 29, 2024|
|Estimated Study Completion Date :||August 19, 2024|
Experimental: Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a day
32mg of VERU-111 26mg of VERU-11
Based on the safety and antitumor activity of VERU-111 in the Phase 1b/2 clinical study, VERU-111 is initiating this Phase 3 clinical study of VERU-111 for the treatment of metastatic castration resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent
Other Name: Sabizabulin
Active Comparator: Active control alternative androgen receptor targeting agent
The alternative androgen receptor targeting agent will be administered according to the dosing instructions in the current product prescribing information.
Drug: Enzalutamide, Abiraterone, Darolutamide and Apalutamide
Enzalutamide and abiraterone were chosen as active comparators are both are FDA approved for the treatment of metastatic castration resistant prostate cancer
- Efficacy of VERU-111 in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent [ Time Frame: 360 days ]Radiographic progression-free survival (rPFS) centrally read, which is death or tumor progression as defined by RECIST 1.1 (soft tissue) and PCWG3 (bone).
- Overall Survival [ Time Frame: 360 days ]Overall survival (OS) will be an assessment of time from randomization into the study to all-cause mortality. The analysis will be performed similarly to the primary endpoint.
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): NCT04844749
|Study Chair:||Barnette||Veru Inc.|