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| ID | Type | Description | Link |
|---|---|---|---|
| 81712917PCR2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-000946-14 | EudraCT Number |
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Administrative Decision
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The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP) | Experimental | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive EPI-7386 + AAP to determine the recommended phase 2 dose (RP2D) dose of EPI-7386 in combination with AAP in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with AAP. |
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| Group B: EPI-3786 + Apalutamide | Experimental | Participants with mCRPC will receive EPI-7386 + apalutamide to determine RP2D dose of EPI-7386 in combination with apalutamide in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with apalutamide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPI-7386 | Drug | EPI-7386 will be administered orally once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 3 Years 3 Months |
| Number of Participants with AEs by Severity | Number of participants with AEs by severity will be reported. | Up to 3 Years 3 Months |
| Number of Participants with Dose-limiting Toxicities (DLT) | The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. | Up to 28 days of Cycle 1 (each cycle of 28 days) |
| Composite Response Rate | Composite response rate at 12 weeks, defined as either 90 percent (%) reduction in prostate-specific antigen (PSA) level from baseline (PSA-90), or objective response (confirmed per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in participants with measurable disease, or both at 12 weeks. | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Abiraterone | Cmax is defined as the maximum observed serum concentration of EPI-7386 and abiraterone. | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and Abiraterone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States | ||
| GU Research Network |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Abiraterone Acetate | Drug | Abiraterone Acetate will be administered orally once daily. |
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| Prednisone or Prednisolone | Drug | Prednisone or Prednisolone will be administered orally twice daily. |
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| Apalutamide | Drug | Apalutamide will be administered orally once daily. |
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Tmax is defined as the time to reach maximum observed serum concentration of EPI-7386 and abiraterone. |
| Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Abiraterone | AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of EPI-7386 and abiraterone. | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Abiraterone | Cmin is the minimum observed serum concentration of EPI-7386 and abiraterone. | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Abiraterone | The observed accumulation ratio for Cmax, determined after multiple dose administration of EPI-7386 and abiraterone (Cycle[C] 2 Day[D] 1/C1D1 and C3D1/C1D1). | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Abiraterone | The observed accumulation ratio for AUCtau, determined after multiple dose administration of EPI-7386 and abiraterone (C2D1/C1D1 and C3D1/C1D1). | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Apalutamide | Cmax is defined as the maximum observed serum concentration of EPI-7386 and apalutamide. | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and apalutamide | Tmax is defined as the time to reach maximum observed serum concentration of EPI-7386 and apalutamide. | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Apalutamide | AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of EPI-7386 and apalutamide. | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Apalutamide | Cmin is the minimum observed serum concentration of EPI-7386 and apalutamide. | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Apalutamide | The observed accumulation ratio for Cmax, determined after multiple dose administration EPI-7386 and apalutamide (C2D1/C1D1 and C3D1/C1D1). | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Apalutamide | The observed accumulation ratio for AUCtau, determined after multiple dose administration EPI-7386 and Apalutamide (C2D1/C1D1 and C3D1/C1D1). | Day 1 of each cycle up to 3 cycles (each cycle of 28 days) |
| Serum Prostate-Specific Antigen (PSA) | Serum PSA concentration will be measured. | Up to 3 Years 3 Months |
| Omaha |
| Nebraska |
| 68130 |
| United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Prostate Cancer Centre | Calgary | Alberta | T2V 1P9 | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| C572045 | apalutamide |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
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