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This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced/metastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCC-2812 | Experimental | Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCC-2812 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting Toxicities (DLTs) | Cycle 1 (28 days) | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 42 months | |
| Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs | Up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 42 months | |
| Radiographic Duration of Response (rDOR) per RECIST v1.1 | Up to 42 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Team | Contact | 888-724-3274 | clinicaltrials@deciphera.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Team | Deciphera Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| PK: Maximum Observed Plasma Drug Concentration (Cmax) | Predose up to 24 hours postdose (up to 42 months) |
| PK: Time to Reach Cmax (Tmax) | Predose up to 24 hours postdose (up to 42 months) |
| PK: Area Under the Plasma Concentration-time Curve (AUC) | Predose up to 24 hours postdose (up to 42 months) |
| PK: Trough Plasma Concentration (Ctrough) | Predose up to 24 hours postdose (up to 42 months) |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Vanderbilt- Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| NEXT Oncology, Austin | Recruiting | Austin | Texas | 78758 | United States |
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| NEXT Oncology, San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |