What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as MET receptor tyrosine kinase inhibitors like Tepotinib, often cause gastrointestinal issues (nausea, diarrhea), skin reactions (rash), and hematologic effects (neutropenia). When combined with other treatments like temozolomide, additional side effects can include myelosuppression, leading to thrombocytopenia and lymphopenia. Radiation therapy can further exacerbate these hematologic effects.

What prior FDA approvals exist?

FDA approvals for the treatment of brain tumors have included various targeted therapies and chemotherapeutic agents. While specific MET receptor tyrosine kinase inhibitors like tepotinib are still under investigation, other targeted therapies such as dabrafenib and trametinib have been approved for BRAF V600E-mutant gliomas. Additionally, temozolomide is a widely used chemotherapeutic agent for glioblastoma. Bevacizumab, an anti-angiogenic drug, has also been approved for recurrent glioblastoma. These treatments represent a range of approaches targeting specific genetic mutations and pathways involved in brain tumor growth.

What other types of research exist?

Promising alternatives to Tepotinib for brain tumor patients include: 1) Abemaciclib, which has shown efficacy in brain metastases from hormone receptor-positive breast cancer. 2) Tucatinib combined with Trastuzumab and Capecitabine, effective in HER2-positive breast cancer brain metastases. 3) Pembrolizumab, an immunotherapy showing promise in non-small cell lung cancer brain metastases. 4) Bevacizumab and Everolimus, which have been used in treating recurrent meningiomas. 5) Lapatinib combined with Capecitabine, effective in HER2-positive breast cancer brain metastases.

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Small Molecule Inhibitor

Tepotinib +/- Osimertinib for Brain Cancer

Phase 1

Waitlist Available

Led By Barbara O'Brien, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Summary

This trial will assess the safety and efficacy of tepotinib in patients with brain tumors and MET alterations. The study will be conducted in two parts, with the first part exploring different doses of the drug and the second part expanding upon the most promising dose from the first part.

Who is the study for?

This trial is for adults with brain tumors or metastases who have MET alterations. It includes those with glioblastoma, patients who've had prior cancer treatments, and NSCLC patients resistant to EGFR-TKI therapy with MET amplification. Participants must be in good physical condition, not pregnant or breastfeeding, willing to use birth control, and able to undergo lumbar puncture without medical risks.Check my eligibility

What is being tested?

The study tests the drug tepotinib alone or combined with osimertinib in people with brain tumors due to MET gene changes. The first phase determines safe dosages while the second expands testing at these doses. Some participants will also undergo surgery as part of their treatment evaluation.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related responses (like fever or chills), fatigue, digestive issues like nausea or diarrhea, blood cell count changes which can affect immunity and healing capacity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the recommended phase II dose (RP2D) of tepotinib for patients with brain metastasis and MET alterations (Group A)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment2 Interventions

will receive tepotinib and osimertinib

Group II: Group AExperimental Treatment1 Intervention

will receive tepotinib alone

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors, such as glioblastomas and brain metastases, often target specific molecular pathways involved in tumor growth and survival. Tepotinib, a MET receptor tyrosine kinase inhibitor, works by blocking the MET signaling pathway, which is often altered in brain tumors and contributes to tumor growth and metastasis. Other treatments, like temozolomide, an alkylating agent, damage the DNA of cancer cells, leading to cell death. Targeted therapies, such as osimertinib for EGFR-mutated tumors, inhibit specific proteins involved in tumor cell proliferation. These mechanisms are crucial for brain tumor patients as they offer more personalized and potentially effective treatment options, targeting the specific genetic and molecular abnormalities driving their cancer.

A phase II study of dose-dense temozolomide and lapatinib for recurrent low-grade and anaplastic supratentorial, infratentorial, and spinal cord ependymoma.Targeted Therapy with Anlotinib for a Patient with an Oncogenic FGFR3-TACC3 Fusion and Recurrent Glioblastoma.Bioinformatics analysis reveals potential candidate drugs for different subtypes of glioma.

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,002 Previous Clinical Trials

1,794,279 Total Patients Enrolled

Barbara O'Brien, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

4,675 Total Patients Enrolled

Media Library

Tepotinib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05120960 — Phase 1

Brain Tumor Research Study Groups: Group B, Group A

Brain Tumor Clinical Trial 2023: Tepotinib Highlights & Side Effects. Trial Name: NCT05120960 — Phase 1

Tepotinib (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05120960 — Phase 1

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