Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

All Drugs and Chemicals

Androgens

The alternative androgen receptor targeting agent will be administered according to the dosing instructions in the current product prescribing information.

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

VERU-111

Enzalutamide and abiraterone were chosen as active comparators are both are FDA approved for the treatment of metastatic castration resistant prostate cancer

Enzalutamide, Abiraterone

Barnette

To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.

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.

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.

Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent

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

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 (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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent	NCT04844749	Metastatic Cast... Androgen Resist...	VERU-111 Enzalutamide, A...	18 Years - 100 Years	Veru Inc.
Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent	NCT04844749	Metastatic Cast... Androgen Resist...	VERU-111 Enzalutamide, A...	18 Years - 100 Years	Veru Inc.

Spots Global Cancer Trial Database for androgen resistant prostatic cancer