BridgeMD
New treatment option for Pediatric Low-grade Glioma
Official title Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK
ClinicalTrials.gov ID: NCT06666348
What this study is testing
What is Mirdametinib?
Mirdametinib is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for pediatric low-grade glioma.
Also referred to as Vinblastine.
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
- This is a 3-part open-label study (feasibility phase, treatment phase and follow-up phase) of orally administered mirdametinib in combination with intravenous vinblastine chemotherapy in patients with PLGG with activation of MAPK pathway. Feasibility Phase: The maximum tolerated/recommended phase 2 dose (MTD/RP2D) of the mirdametinib plus vinblastine combination will be assessed using a modified Rolling-6 design.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 25
You may be able to join if
- Signed written informed consent prior to study participation.
- Study activities compliance: must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements...
- Aged ≥ 2 years to ≤ 25 years when starting mirdametinib.
- BSA ≥ 0,40m2
- Diagnosis: Participants must have PLGG with NF1 gene mutation (based on clinical NIH criteria, germline NF1 mutation or molecular analysis of the...
You likely can't join if
- Patients who are receiving other investigational agents.
- Cardiac: QTcB ≥ 480 msec or an absolute resting left ventricular ejection fraction (LVEF) of ≤ 49%.
- Patients who have any other malignancy, except if the other primary malignancy is neither currently clinically significant nor requiring active...
- Tumor with BRAF V600E mutation.
- Patients who received previous systemic or radiotherapy treatment.
- Other severe and uncontrollable medical disease
See the full eligibility criteria
- Signed written informed consent prior to study participation.
- Study activities compliance: must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study, including disease assessment by contrast enhanced MRI.
- Aged ≥ 2 years to ≤ 25 years when starting mirdametinib.
- BSA ≥ 0,40m2
- Diagnosis: Participants must have PLGG with NF1 gene mutation (based on clinical NIH criteria, germline NF1 mutation or molecular analysis of the tumor) or PLGG with KIAA1549-BRAF fusion (based on molecular analysis of...
- Tumor tissue is required (at minimum, paraffin-embedded tissue block and additionally fresh frozen tissue [if available]). Patients with NF1 and Low Grade Glioma (LGG) can still be enrolled without tissue if no surgery...
- Baseline MRI.
- Life expectancy greater than 6 months.
- Lansky/Karnofsky score ≥ 50.
- Normal organ and marrow function (see study protocol for specifics).
- Female and male patients of fertile age must agree to use highly effective contraceptive measures.
- Must be able to ingest by mouth and retain entirely the administered medication. Mirdametinib can not be administered via nasogastric tube or gastrostomy tube.
- Patients who are receiving other investigational agents.
- Cardiac: QTcB ≥ 480 msec or an absolute resting left ventricular ejection fraction (LVEF) of ≤ 49%.
- Patients who have any other malignancy, except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
- Tumor with BRAF V600E mutation.
- Patients who received previous systemic or radiotherapy treatment.
- Other severe and uncontrollable medical disease
- Blood pressure higher than 95th percentile for patient's age, height and gender.
- Increased risk of serious retinopathy and retinal vein occlusion.
- Known diagnosis of human immunodeficiency virus infection, hepatitis B or C.
- Previous major surgery within 2 weeks.
- History of allergic reactions to compounds of similar chemical or biological composition to mirdametinib.
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
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, 2 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada and 2 more location(s). 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.