A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Di… (NCT04771897) | Clinical Trial Compass
TerminatedPhase 1
A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)
Stopped: Bexion Pharmaceuticals has decided to close the BXQ-350.AD study to enrollment prior to the anticipated enrollment goal. Justification for this decision is due to slow enrollment and the competitive landscape of the indication.
United States10 participantsStarted 2021-05-24
Plain-language summary
This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children with newly diagnosed DIPG or DMG. All patients will receive BXQ-350 by intravenous (IV) infusion and radiation therapy. The study is divided into two parts: Part 1 will enroll patients at increasing dose levels of BXQ-350 in order to determine the MTD. Part 2 will enroll patients requiring a biopsy in order to assess BXQ-350 concentrations in the biopsied tumor.
Who can participate
Age range1 Year – 30 Years
SexALL
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Inclusion criteria
✓. Provide signed, written informed consent prior to the initiation of any study-specific procedures (consent from guardians for minor children and patient assent according to institution and Institutional Review Board (IRB) standards)
✓. Age ≥ 1 year of age and ≤ 30 years of age at the time of study entry
✓. Have radiographically suspected or histologically confirmed newly diagnosed DIPG or DMG with the following defining disease characteristics/features:
✓. If receiving glucocorticoid therapy: dexamethasone allowed with maximum allowable dose 16mg/day
✓. Have measurable or non-measurable disease per RANO criteria
✓. Have Lansky (age 1 - 15) / Karnofsky (age ≥ 16) Performance Score of ≥ 50% or Eastern Cooperative Oncology Group (ECOG) Performance Status (age ≥ 18) of 0 - 2
✓. Have acceptable liver function defined as:
✓. Have acceptable renal function defined as:
Exclusion criteria
What they're measuring
1
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
✕. Have received prior treatment with radiation, chemotherapy, anti-neoplastic, or investigational agents
✕. Have had major surgery other than a minor outpatient procedure within 28 days prior to dose assignment or have not recovered from major side effects of the surgery if more than 4 weeks have elapsed since surgery
✕. Have poorly controlled hypertension despite the use of antihypertensive agents defined as blood pressure ≥95th percentile for age and weight or \>160/90 on at least 2 repeated determinations on separate days within 2 weeks (14 days) prior to initiation of screening
✕. Have a history of cardiac dysfunction including:
✕. Have a known history of Human Immunodeficiency Virus (HIV) seropositivity
✕. Have active (acute or chronic) or uncontrolled severe infections