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| Name | Class |
|---|---|
| Enviro Therapeutics, Inc. | UNKNOWN |
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This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apalutamide monotherapy | Active Comparator | After progression, subjects will crossover to combination therapy |
|
| Combination therapy (Apalutamide + Carotuximab) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab | From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause. | From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide | Grade 3 or above treatment related adverse events as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | From start of study treatment through 4 weeks on treatment |
| Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Recruitment Navigator | Contact | 3104232133 | cancer.trial.info@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Edwin Posadas, MD FACP | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
| C579557 | carotuximab |
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| Carotuximab | Drug | Carotuximab administered intravenously at the following doses: Cycle 1 Day 1: 3 mg/kg Cycle 1 Day 4: 7 mg/kg Cycle 1 Day 8: 10 mg/kg Cycle 1 Day 15: 10 mg/kg Cycle 1 Day 22: 10 mg/kg Cycle 2 Day 1: 15 mg/kg Cycle 2 Day 15: 15 mg/kg Cycle 3+ Day 1: 15 mg/kg After completion of cycle 2, dosing of carotuximab will continue at a q4 week schedule using the 15 mg/kg dose. |
|
Participants of the combination of apalutamide + carotuximab, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3 |
| From the start of combination study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. |
| Proportion of patients resistant to apalutamide benefit from the addition of carotuximab | Participants of the monotherapy group that crossover to combination therapy at progression, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3 | From the start of combination therapy study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. |
| Overall radiographic response rate (ORR) in the overall population | Determined by confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3 | From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. |
| To determine the radiographic progression free survival (rPFS) in the overall population | From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause. | From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. |
| To determine the biochemical PFS (by PCWG3) in the overall population | From the start of study treatment until documented progression, per Prostate Cancer Working Group 3, or death due to any cause. | From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. |
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
|
| Huntsman Cancer Institute and Hospital | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |