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The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCC-3009 Module A | Experimental | Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCC-3009 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation) | DLTs assessed for each dose level. | Cycle 1 (28 Days) |
| Objective Response Rate (ORR) (Part 2 Expansion) | ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST), v1.1. | Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Part 1 Escalation) | ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on mRECIST, v1.1. | Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months) |
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Inclusion Criteria:
Module A Part 1 (Escalation):
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 |
|---|---|---|---|---|---|---|
| HonorHealth | Recruiting | Scottsdate | Arizona | 85258 | United States |
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| Duration of Response (DOR) |
DOR for participants with confirmed CR or confirmed PR based on mRECIST, v1.1, defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the disease progression is objectively documented or death, whichever occurs first. |
| First Recorded CR or PR until PD or Death (Estimated up to 24 months) |
| Progression-Free Survival (PFS) | PFS is the time from initiation of treatment until documented disease progression per mRECIST, v1.1, or death, whichever occurs first. | Initiation of Treatment to PD or Death (Estimated up to 24 months) |
| Overall Survival (OS) | OS is the time from initiation of treatment to the date of death from any cause. | Initiation of Treatment to Death from Any Cause (Estimated up to 24 months) |
| Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) | Cmax | Estimated up to 24 months |
| UC San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| University of Miami - Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
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| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Vanderbilt University-Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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