Solid tumors driven by the MAPK Pathway
Conditions
Brief summary
Part 1: Number of Participants with Dose-limiting Toxicities (DLTs), Part 2: Objective Response Rate (ORR); ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
Detailed description
1. Part 1: ORR (the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol), 2. Part 1 and 2: Progression-Free Survival (PFS). PFS is the time from start of therapy to PD or death due to any cause., 3. Part 1 and 2: Overall Survival (OS). OS is the time from start of therapy to death from any cause., 4. Part 1 and 2: Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)
Interventions
DRUGDCC-3084
Sponsors
Deciphera Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of Participants with Dose-limiting Toxicities (DLTs), Part 2: Objective Response Rate (ORR); ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Part 1: ORR (the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol), 2. Part 1 and 2: Progression-Free Survival (PFS). PFS is the time from start of therapy to PD or death due to any cause., 3. Part 1 and 2: Overall Survival (OS). OS is the time from start of therapy to death from any cause., 4. Part 1 and 2: Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) | — |
Countries
France, Germany, Spain
Outcome results
None listed