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New treatment option for Glioblastoma
Official title A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma
ClinicalTrials.gov ID: NCT06552260
What this study is testing
What is Troriluzole?
Troriluzole is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioblastoma.
Also referred to as Trigriluzole, BHV-4157.
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 research study is studying troriluzole as a possible treatment for recurrent glioblastoma. The name of the study drug involved in this research study is: -Troriluzole (a tripeptide prodrug of riluzole)
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Age ≥18 years
- Histopathologically confirmed IDH-wildtype glioblastoma, WHO Grade 4, and variants including gliosarcoma as per WHO 2021 criteria (38).
- Prior treatment with radiotherapy with or without chemotherapy.
- Recurrent or progressive disease with no more than 2 prior relapses.
- Confirmed measurable disease per RANO 2.0 for GBM.
You likely can't join if
- Laboratory values at the Screening Visit:
- ANC count \< 1,500/mm3; growth-factor support within 7 days for filgrastim or other short acting biosimilars or 21 days for pegfilgrastim or other...
- Platelets \<100,000/mm3;
- Hemoglobin \< 9 g/dL;
- Total bilirubin \> 2 × the upper limit of normal (ULN) (unless subject has documented history of Gilbert's Syndrome in which case subject may be...
- Aspartate aminotransferase (AST [SGOT]) \> 1.5 x ULN;
See the full eligibility criteria
Who can join
- Age ≥18 years
- Histopathologically confirmed IDH-wildtype glioblastoma, WHO Grade 4, and variants including gliosarcoma as per WHO 2021 criteria (38).
- Prior treatment with radiotherapy with or without chemotherapy.
- Recurrent or progressive disease with no more than 2 prior relapses.
- Confirmed measurable disease per RANO 2.0 for GBM.
- Tumor is documented as IDH1/2 wildtype by direct DNA sequencing, provided that it is performed in a CLIA/CAP-certified laboratory.
- Availability of archival formalin fixed paraffin-embedded (FFPE) tumor tissue block or 20 unstained FFPE slides (5 μm thick) from any prior surgery for mutation testing and additional sequencing.
- Karnofsky Performance Status of ≥ 60.
- Candidate for surgical resection.
- Tumor tissue extending to cortical gray matter based on MRI.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Women of child-bearing potential (WOCBP), defined as any individual assigned female at birth physiologically capable of becoming pregnant, must use highly effective contraception during study treatment and for 1 month...
- True Abstinence: When this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable...
- Sterilization: Surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by...
- Male Partner Sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female people on the study, the vasectomised male partner should be the sole partner for that...
- A barrier method defined as condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository along with a second contraceptive method as described below:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Appropriate hormonal contraceptives (including any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent - including oral, subcutaneous, intrauterine
- Male people should agree to use a highly effective method of contraception starting with the first dose of study therapy through 3 months after the last dose of therapy. Male people must not donate semen for 3 months...
- Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
What rules you out
- Laboratory values at the Screening Visit:
- ANC count \< 1,500/mm3; growth-factor support within 7 days for filgrastim or other short acting biosimilars or 21 days for pegfilgrastim or other long acting biosimilars to increase the ANC is not allowed.
- Platelets \<100,000/mm3;
- Hemoglobin \< 9 g/dL;
- Total bilirubin \> 2 × the upper limit of normal (ULN) (unless subject has documented history of Gilbert's Syndrome in which case subject may be enrolled if total bilirubin is less than 5 mg/dL, assuming all other...
- Aspartate aminotransferase (AST [SGOT]) \> 1.5 x ULN;
- Alanine aminotransferase (ALT [SGPT]) \> 1.5 x ULN;
- Serum creatinine \> 1.5 mg/dL or a calculated creatinine clearance \< 60 mL/min; and
- Positive serum β-hCG test in any individual assigned female at birth and is of childbearing potential (defined as ≤ 50 years of age, or \> 50 years of age with a history of amenorrhea for ≤12 months prior to study...
- Has presence of diffuse leptomeningeal disease or extracranial disease.
- Prior treatment with troriluzole or riluzole
- From study treatment initiation, treatment with temozolomide less than 23 days, treatment with CCNU or BCNU less than 42 days, treatment with anti-VEGF therapy such as bevacizumab less than 6 months, or treatment with...
- Use of any investigational agents within 28 days of baseline or 5 half-lives from study initiation, whichever is shorter.
- Radiotherapy within 12 weeks prior to registration unless new enhancement is outside the radiation field (beyond the high-dose region of 80% isodense line) or evidence of viable tumor on histopathologic sampling.
- Presence of a clinically significant allergy, hypersensitivity, or toxicity of prior therapy, with the exception of alopecia or lymphopenia, that has not resolved to ≤ Grade 1 or pre-treatment baseline, as determined by...
- Major surgery within 28 days prior to initiation of study drug.
- Active or clinically unstable bacterial, viral, or fungal infection requiring systemic therapy.
- Any contraindication to MRI examination.
- Requires medications that are known to be strong inhibitors or inducers of CYP1A2 enzymes or anti-glutamergic agents (e.g., perampanel) or hepatotoxic drugs which may increase the risk of hepatotoxicity (e.g...
- Pregnant or lactating female.
- History of interstitial lung disease.
- Known history of hepatitis B, human immunodeficiency virus (HIV), or active hepatitis C infection requiring treatment with antiviral therapy. NOTE: HIV testing is not required in the absence of clinical suspicion.
- Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed...
- Difficulty swallowing or malabsorption syndrome; refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection with clinically significant sequelae that would preclude...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
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 Boston, Massachusetts, United States. 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.