Actively Recruiting
Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas: Phase 1 Study
Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-08-06
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the combination of two drugs, Alpelisib and Trametinib, for treating aggressive meningiomas that have resisted multiple surgeries and radiotherapy. These tumors, particularly grade II-III meningiomas, have a low progression-free survival rate, and current treatments do not effectively induce tumor cell death. The study aims to determine the safety and appropriate dosing of this drug combination in patients with these hard-to-treat brain tumors. The study is a multicenter, open-label, phase 1 trial where patients receive a fixed daily dose of Trametinib (1.5 mg) combined with varying doses of Alpelisib, starting at 160 mg per day and adjusted based on the occurrence of severe side effects. This dose-finding phase will help identify the maximum tolerated dose and recommended dose for future studies. Patients will undergo MRI scans with contrast before starting treatment to assess tumor growth and have blood samples collected to monitor therapeutic biomarkers. Participants will be monitored for dose-limiting toxicities during the first treatment cycle, with safety and tolerability as primary outcomes. Assessments include regular clinical evaluations and laboratory tests to confirm adequate organ function. The trial will last up to 36 months, focusing on the rate of dose-limiting toxicities. The study excludes patients with uncontrolled diabetes, other recent cancers, or certain medical conditions, ensuring participants meet specific health criteria before enrollment.
CONDITIONS
Brief Title
Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven meningioma grade I, II and III
- Progression defined as growing meningiomas on 2 different MRI scans 3 to 6 months apart
- Patients must have failed surgery and not be eligible for new curative surgery
- Patients must have failed radiotherapy and/or radiosurgery
- Patients who have provided written informed consent
- No contraindication to Alpelisib and Trametinib
- Not receiving other investigational agents
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
You will not qualify if you...
- Contraindication to Alpelisib and Trametinib
- Women of child-bearing age not using effective contraception
- Pregnant or breastfeeding women
- Receiving other investigational agents
- Known intolerance or hypersensitivity to Alpelisib and Trametinib
- Uncontrolled diabetes mellitus
- Severe and uncontrolled medical conditions
- Chronic treatment with immunosuppressives
- Known history of HIV seropositivity
- History of another primary malignancy within 3 years, except non-melanoma skin cancer and carcinoma in situ of uterine cervix
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 36 months
Participants receive a combination of Alpelisib at one of three possible doses and a fixed daily dose of Trametinib (1.5 mg) to assess safety and side effects.
Trial Site Locations
Total: 1 location
1
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354
Actively Recruiting
Research Team
T
Thomas GRAILLON, PH
O
Olivier CHINOT, PU-PH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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