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New treatment option for Meningioma
Official title Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas
ClinicalTrials.gov ID: NCT03631953
What this study is testing
What is Trametinib?
Trametinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for meningioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Aggressive growing meningiomas resistant to multiple surgeries and radiotherapy constitute an unmet pharmaceutical need in neurooncology, leading to a fatal issue within a few months. Grade II-III meningiomas progression-free survival (PFS) 6 is at 10-15%.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically proven meningioma grade I, II and III
- Progression is defined as growing meningiomas on 2 different Magnetic Resonance Imaging (MRI) 3 to 6 months apart
- Patients must have failed surgery, and not amenable to a new curative intended surgery
- Patients must have failed radiotherapy and/or radiosurgery
- Patients who have given their written consent
You likely can't join if
- Contra indication to Alpelisib and Trametinib
- Women of child-bearing age who are using no effective means of contraception
- Pregnant or breast-feeding women
- Patients receiving other investigational agents
- Known intolerance or hypersensitivity to Alpelisib and Trametinib
- Uncontrolled diabetes mellitus
See the full eligibility criteria
- Histologically proven meningioma grade I, II and III
- Progression is defined as growing meningiomas on 2 different Magnetic Resonance Imaging (MRI) 3 to 6 months apart
- Patients must have failed surgery, and not amenable to a new curative intended surgery
- Patients must have failed radiotherapy and/or radiosurgery
- Patients who have given their written consent
- No contra indication to Alpelisib and Trametinib
- No receiving other investigational agents
- Written informed consent
- Adequate bone marrow function
- Adequate liver function as shown by
- Adequate renal function
- Contra indication to Alpelisib and Trametinib
- Women of child-bearing age who are using no effective means of contraception
- Pregnant or breast-feeding women
- Patients receiving other investigational agents
- Known intolerance or hypersensitivity to Alpelisib and Trametinib
- Uncontrolled diabetes mellitus
- Patients who have any severe and uncontrolled medical condition
- Patients receiving chronic treatment with immunosuppressives
- Patients with a known history of HIV seropositivity
- Patients who have a history of another primary malignancy less than or equal to 3 years, with
- the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.