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A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations
To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors * To evaluate the safety and tolerability of naporafenib administered with trametinib in patients with RAS Q61X solid tumors * To characterize the pharmacokinetic (PK) profile of naporafenib and trametinib when administered to patients with RAS Q61X solid tumors.
Study details:
SEACRAFT-1 is an open-label study to assess the safety and efficacy of naporafenib administered with trametinib in previously treated patients with locally advanced unresectable or metastatic RAS Q61X solid tumor malignancies. The study will enroll a total of approximately 100 adult patients; a sub-study will enroll approximately 15 adolescent patients ≥12 and \<18 years for a total sample size of approximately 115. Patients with a locally advanced unresectable or metastatic solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy are eligible.
Patients with primary central nervous system (CNS) tumors are not eligible. Documentation of a RAS Q61X mutation in tumor tissue prior to the first dose of study treatment is required.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-08-17
Primary completion: 2025-07-01
Study completion finish: 2025-11-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05907304
Intervention or treatment
DRUG: Naporafenib
DRUG: Trametinib
Conditions
- • Advanced or Metastatic Solid Tumors
Find a site
Closest Location:
Macquarie University
Research sites nearby
Select from list below to view details:
Macquarie University
Macquarie Park, New South Wales, Australia
St. Vincent's Hospital
Melbourne, Victoria, Australia
Linear Clinical Research, LTD
Perth, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Naporafenib + Trametinib
| DRUG: Naporafenib
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors | Based on assessment of Objective response rate (ORR) per RECIST version 1.1 | Assessed up to 24 months from time of first dose |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Adverse Events | Incidence and severity of treatment-emergent AEs and serious AEs | Assessed up to 24 months from time of first dose |
Duration of Response (DOR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Assessed up to 24 months from time of first dose |
Time to Response (TTR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Assessed up to 24 months from time of first dose |
Progression Free Survival (PFS) | Based on assessment of radiographic imaging per RECIST version 1.1 | Assessed up to 24 months from time of first dose |
Disease Control Rate (DCR) | Based on assessment of radiographic imaging per RECIST version 1.1 | Assessed up to 24 months from time of first dose |
Plasma concentration (Cmax) | Maximum plasma concentration of ERAS-254 and trametinib | Study Day 1 up to Day 29 |
Time to achieve Cmax (Tmax) | Time to achieve maximum plasma concentration of ERAS-254 and trametinib | Study Day 1 up to Day 29 |
Area under the curve (AUC) | Area under the plasma concentration-time curve | Study Day 1 up to Day 29 |
Overall survival | Survival Status | Assessed up to 24 months from time of first dose |
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