Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated… (NCT03050736) | Clinical Trial Compass
CompletedPhase 2
Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression
China29 participantsStarted 2017-12-17
Plain-language summary
The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
Who can participate
Age range18 Years – 69 Years
SexALL
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✓. Tumor tissue specimens from the GBM surgery or open biopsy must be available for MGMT gene promoter status analysis and central pathology review.
✓. Documented unmethylated MGMT gene promoter status
✓. Males or females ≥18\< 70 years of age.
✓. Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
✓. Cranial MRI must have been performed within 21 days of study entry and MRI must be used throughout the period of protocol treatment for tumor measurement. If the surgical procedure was a resection, cranial MRI performed within 72 hours of resection is preferred
✓. Stable or decreasing dose of steroids for ≥5 days prior to randomization.
✓. Karnofsky performance score ≥ 70%
Exclusion criteria
✕. Prior chemotherapy within the last 5 years.
✕. Prior radiation therapy of the head.
✕. Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of VAL-083.
✕. Prior systemic anti-angiogenic therapy.
What they're measuring
1
Efficacy evaluation of tumor response in patients, as measured by magnetic resonance imaging
Timeframe: Every 42 days while receiving radiotherapy then every 63 days while remaining on study, from patient randomization until study discontinuation for up to 10 months
✕. Planned surgery for other diseases (e.g. dental extraction).
✕. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
✕. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥5 years are eligible for this study.