The Clinical Trial to Evaluate the Pharmacokinetics and Safety of MRTX849 in Patients With Advanc… (NCT05263986) | Clinical Trial Compass
UnknownPhase 1
The Clinical Trial to Evaluate the Pharmacokinetics and Safety of MRTX849 in Patients With Advanced Solid Tumors
China22 participantsStarted 2022-05-30
Plain-language summary
This is a phase 1, open-label, single-arm study in Chinese patients with unresectable, locally advanced or metastatic solid tumor with KRAS G12C mutation, for which treatment with curative intent is not available.
Patients must have a documented KRAS G12C mutation determined by tissue or liquid-based local testing.
The PK profile of MRTX849 in Chinese patients will be evaluated after administration of a single and repeat oral doses of 600 mg BID. In the PK lead-in period, blood samples will be collected pre-dose and up to 96 hours post a single oral dose of 600 mg MRTX849. Following this lead-in period, patients will start the dosing regimen of 600 mg BID orally, and blood samples will be collected pre-dose and up to 12 hours after multiple doses of MRTX849 600 mg BID on Cycle 1 Day 8 (C1D8).
Safety including AEs, ECGs, laboratory parameters and vital signs of each patient will be monitored throughout the conduct of the study.
Disease response and progression will be evaluated in accordance with Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. no available treatment with curative intent,
. no available standard-of-care treatment or patient is ineligible or declines treatment.
. Absolute neutrophil count ≥ 1,000/mm3 (≥ 1.0 x 109/L)
. Platelet count ≥ 100,000/mm3 (≥ 100 x 109/L)
. Hemoglobin ≥ 9 g/dL, in the absence of transfusions for at least 2 weeks
. Total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) (if associated with liver metastases or Gilbert's disease, ≤ 3 x ULN)
. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (if associated with liver metastases, ≤ 5 x ULN)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Main PK parameters: Cmax
Timeframe: Approximately 2 weeks after dose initiation
2
Main PK parameters: Tmax
Timeframe: Approximately 2 weeks after dose initiation
3
Main PK parameters: AUC0-12
Timeframe: Approximately 12 hours after dose initiation
4
Main PK parameters: AUC0-t
Timeframe: Approximately 2 weeks after dose initiation
5
Main PK parameters: AUC0-∞
Timeframe: Approximately 2 weeks after dose initiation
6
Main PK parameters: t1/2
Timeframe: Approximately 2 weeks after dose initiation
7
Main PK parameters: CL/F
Timeframe: Approximately 2 weeks after dose initiation
. Inhibitors of CYP3A4, CYP2C8, P-glycoprotein (P-gp), or breast cancer resistance protein (BCRP) within 7 days or 5 half-lives, whichever is longer, prior to MRTX849 dosing initiation.
. Inducers of CYP3A4 or CYP2C8 within 14 days or 5 half-lives, whichever is longer, prior to MRTX849 dosing initiation.
. Proton-pump inhibitors within 7 days or 5 half-lives, whichever is longer, prior to MRTX849 dosing initiation.
. Unstable angina pectoris or myocardial infarction within 6 months prior to
. Symptomatic or uncontrolled atrial fibrillation within 6 months prior to
. Congestive heart failure ≥ New York Heart Association (NYHA) Class 3 within 6 months prior to MRTX849 dosing initiation.
. Prolonged QTc interval \> 480 milliseconds.
. Patients treated for hepatitis C (HCV) with no detectable viral load;
Main PK parameters: Vz/F
Timeframe: Approximately 2 weeks after dose initiation
9
Main PK parameters: Cmax, ss
Timeframe: Approximately 2 weeks after dose initiation
10
Main PK parameters: Tmax, ss
Timeframe: Approximately 2 weeks after dose initiation
11
Main PK parameters: Cmin, ss
Timeframe: Approximately 2 weeks after dose initiation
12
Main PK parameters: Cavg
Timeframe: Approximately 2 weeks after dose initiation
13
Main PK parameters: AUCss
Timeframe: Approximately 2 weeks after dose initiation
14
Main PK parameters: Rac for Cmax and AUCtau
Timeframe: Approximately 2 weeks after dose initiation
15
Main PK parameters: PTR
Timeframe: Approximately 2 weeks after dose initiation