Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (NCT03868943) | Clinical Trial Compass
TerminatedPhase 2
Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma
Stopped: Axsome has conducted a review of the ongoing IST program and are unable to continue supporting this study
United States2 participantsStarted 2021-01-27
Plain-language summary
This phase II trial studies the side effects of solriamfetol in improving sleep in patients with grade II-IV glioma. Solriamfetol is a wakefulness-promoting drug. Giving solriamfetol may improve sleep, memory, fatigue, mood, or quality of life in patients with brain tumors (gliomas).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
WHO Grade 2-4 infiltrating glioma by histologic confirmation
* Where appropriate results from clinically available testing of isocitrate dehydrogenase (IDH) gene mutation status (for all gliomas), chromosome 1p and 19q deletion status (for suspected oligodendrogliomas), and MGMT gene promoter methylation status (for malignant gliomas) must be available in the patient's chart.
* These studies are standard of care molecular studies that are performed as a part of routine clinical practice and allow for integrated molecular subtyping of primary glial tumors.
Epworth Sleepiness Scale (ESS) score \>10 within 21 days of enrollment
Clinical and/or radiographic evidence of stable disease within 21 days of enrollment
* Patients must have completed concurrent chemoradiation with recovery of all pre-existing toxicity to CTCAE Grade \>1
* Patient who are anticipated to undergo surgery and/or radiation therapy for management of their tumor during the duration of study treatment are NOT eligible.
* Patients who are anticipated to undergo adjuvant chemotherapy are eligible as long as there is no evidence of tumor progression by clinical exam and/or imaging within 21 days of enrollment (see 4.1.2). This determination should be made by clinical documentation and if there is question discussed with the Study Chair. Adjuvant chemotherapy is not an exclusion.
* Patients who are currently undergoing chemotherapy, targeted therapy, immunotherapy, or salvage treatment and h…
What they're measuring
1
Proportion With Grade 3 or Higher Adverse Events
Timeframe: Duration of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)