A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive P… (NCT03257631) | Clinical Trial Compass
CompletedPhase 2
A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors
United States53 participantsStarted 2017-09-18
Plain-language summary
This study will assess the efficacy, safety and tolerability of pomalidomide in children and young adults aged 1 to \< 21 years with recurrent or progressive primary brain tumors in one of four primary brain tumor types: high-grade glioma (HGG), medulloblastoma, ependymoma and diffuse intrinsic pontine glioma (DIPG).
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion criteria
✓. Subject is 1 to \< 21 years of age at the time of signing the Informed Consent Form/Informed Assent Form (ICF/IAF).
✓. Subject (when applicable, parental/legal representative) must understand and voluntarily sign an ICF/IAF prior to any study-related assessments/procedures being conducted.
✓. Subject has received at least one prior standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy.
✓. Subject has a diagnosis of high-grade glioma, medulloblastoma, ependymoma or diffuse intrinsic pontine glioma (DIPG) that is recurrent or progressive. Subjects with neurofibromatosis type 1 (NF-1) associated tumors are eligible if they meet all other eligibility criteria.
✓. Subject has histological verification of tumor either at the time of diagnosis or recurrence. Subjects with DIPG are exempt from histologic verification if they have typical magnetic resonance imaging (MRI) findings of DIPG
✓. Subject has measurable disease defined as a tumor that is measurable in 2 perpendicular diameters on MRI. For a lesion to be considered measurable, it must be at least twice the slice thickness on MRI (ie, visible on 2 or more axial slices)
✓. To document the degree of tumor at study baseline, the following scan(s) must be obtained:
✓. Subject has Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status score ≥ 50 at screening
Exclusion criteria
✕. Subject has a history of non-central line related thrombosis (arterial or venous), more than one prior central-line related thrombosis or known coagulopathy.
What they're measuring
1
Percentage of Participants With an Objective Response and Long-term Stable Disease
Timeframe: 6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
✕. Subject has first degree family member with a known hereditary coagulopathy.
✕. Subject is actively on anticoagulation therapy.
✕. Subject has had major (per Investigator discretion) surgery, with the exception of tumor resection, within 21 days from first dose of study drug.
✕. Subject has previously received (presence of any of the following will exclude a subject from enrollment):
✕. Subject has received therapy with a known moderate to potent CYP1A2 inhibitor within 14 days or 5 half-lives of first dose of study treatment (whichever is longer).
✕. Subject has received colony-stimulating growth factor(s) within 7 days prior to screening (or within 14 days if subject received polyethylene glycol formulations).
✕. Subject is pregnant, breast-feeding or lactating.