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Treatment of advanced-stage malignancies harboring BRAF mutations with combination of Sorafenib and Trametinib: a multicenter study
EU CTIS ID: 2024-512887-77-00
What this study is testing
Primary objective: is to determine the maximum tolerated dose (MTD) of trametinib combined with sorafenib and the recommended phase II dose (RP2D) for expansion part of the trial
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female patients aged ≥18 years without upper age limit;
- 10. Written informed consent obtained according to international guidelines and local laws
- 11. Ability to understand the nature of the trial and the trial related procedures and to comply with them
- 2. Metastatic malignancy
- 3. Progression after standard treatment
- 4. BRAF mutation with impaired kinase activity (according to Brummer laboratory at Medical Center – University of Freiburg)
You likely can't join if
- 1. Finding of a strongly activating BRAF mutation
- 18. Concurrent treatment with anticancer therapy (other than IMPs)
- 19. Concomitant use of strong Cytochrome P450 3A4 inducers
- 10. Patients who have received sorafenib in the past
- 20. For female patient: current or planned pregnancy, nursing period
- 21. Failure to use one of the following safe methods of contraception: hormonal contraception in combination with a mechanical method of contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence
See the full eligibility criteria
Who can join
- 1. Male or female patients aged ≥18 years without upper age limit;
- 10. Written informed consent obtained according to international guidelines and local laws
- 11. Ability to understand the nature of the trial and the trial related procedures and to comply with them
- 2. Metastatic malignancy
- 3. Progression after standard treatment
- 4. BRAF mutation with impaired kinase activity (according to Brummer laboratory at Medical Center – University of Freiburg)
- 5. BRAF mutation with sensitivity to sorafenib in vitro (according to Brummer laboratory at Medical Center – University of Freiburg)
- 6. At least one lesion that can be measured by CT, PET-CT, or MRI according to RECIST 1.1
- 7. Adequate hepatic function with • AST and ALT < 3 ULN AND • Total bilirubin < 1.5 x ULN. Patient with Gilberts syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.
- 8. Calculated creatinine clearance ≥ 50 mL/min by the Cockcroft-Gault- Equation
- 9. Patient is able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
What rules you out
- 1. Finding of a strongly activating BRAF mutation
- 18. Concurrent treatment with anticancer therapy (other than IMPs)
- 19. Concomitant use of strong Cytochrome P450 3A4 inducers
- 10. Patients who have received sorafenib in the past
- 20. For female patient: current or planned pregnancy, nursing period
- 21. Failure to use one of the following safe methods of contraception: hormonal contraception in combination with a mechanical method of contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence
- 11. Patient with a known history of aneurysms
- 12. History of retinal vein occlusion (RVO)
- 13. Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
- 2. Life expectancy <3 months
- 3. Patients with hepatocellular carcinoma (HCC) or hepatic cirrhosis
- 6. Uncontrolled bacterial, viral or fungal infection
- 4. Patient with ECOG >2
- 5. Patients with known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening
- Treatment with therapeutic anticoagulation or dual platelets inhibition
- 7. Radiation therapy, major surgery, other locoregional therapy, within 4 weeks prior to the first dose of study drug
- 8. Serious cardiovascular disease (e.g. manifest heart failure, coronary heart disease, uncontrolled hypertension)
- 9. Any serious disease interfering with a regular therapy according to the study protocol
- 14. Ongoing interstitial lung disease or pneumonitis, which requires treatment/medication
- 15. Known hypersensitivity to the active substances or any of the excipients
- 16. Participation in any other interventional clinical trial within the last 30 days before the start of this trial; simultaneous participation in registry and diagnostic trials is allowed
- 17. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.