Advanced Solid Tumor, BRAF Gene Mutation, Castration-Resistant Prostate Cancer (CRPC), CRAF Gene Mutation, Melanoma, NF1 Mutation, Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, RAF Mutation, RAS Mutation
Conditions
Keywords
Advanced malignancies
Brief summary
This is a multicenter clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).
Interventions
DRUGDCC-3084
Administered orally
Sponsors
Deciphera Pharmaceuticals, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria ModA Part 1 and 2: * Able to take oral medication * If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements * Adequate organ function and electrolytes * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1 at Screening * Has a life expectancy of more than 6 months * In addition to these general inclusion criteria, participants must meet all the module cohort-specific inclusion criteria Inclusion Criteria ModA Part 1 Cohort Specific: * Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten rat sarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murine sarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation * Have exhausted all available standard of care therapies that are known to provide benefit for the participant's condition, as judged by the Investigator Inclusion Criteria ModA Part 2 Cohort Specific: * Documented BRAF gene mutation * Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1) | Cycle 1 (28 days) | DLTs reported during ModA Part 1. |
| Objective Response Rate (ORR) (ModA Part 2) | Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months) | 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 | Description |
|---|---|---|
| ORR (ModA Part 1) | Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months) | ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol. |
| Progression-Free Survival (PFS) (ModA Part 1 and 2) | Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months) | PFS is the time from start of therapy to PD or death due to any cause. |
| Overall Survival (OS) (ModA Part 1 and 2) | Start of Therapy to Death Due to Any Cause (Estimated up to 36 months) | OS is the time from start of therapy to death from any cause. |
| Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2) | Predose up to 12 hours postdose | Cmax (ModA Part 1 and 2) |
Countries
United States
Outcome results
None listed