Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma

NCT03868943 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB00056700NCI-2019-01299P30CA012197CCCWFU 98418
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Glioma; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Proportion With Grade 3 or Higher Adverse Events

  National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used for scoring toxicity and adverse events. Score of 1 to 5 (1 = mild, 5 = death). The proportions of subjects who experienced grade 3 or above toxicities will be estimated

  Duration of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

Secondary Outcomes (8)

• Epworth Sleepiness Scale

  End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

• Pittsburgh Sleep Quality Index (PSQI)

  End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

• Neurocognitive Battery Record

  post treatment

• Cancer Fatigue Scale (CFS)

  End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

• Beck's Depression Inventory (BDI)

  End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

Study Arms (1)

Solriamfetol

EXPERIMENTAL

Given orally daily

Drug: Soliramfetol

Interventions

Soliramfetol DRUG

Solriamfetol will be dosed by flexible dose titration starting at 75 mg daily in all patients and escalating after 7 days (1 week) to 150 mg daily and then after 7 days to 300 mg daily for a total duration of 3 weeks (flexible dose titration period).

Solriamfetol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 currently undergoing chemotherapy, targeted therapy, immunotherapy, or salvage treatment and have stable disease by imaging are eligible and can continue the current anti-cancer therapy. Patients who will require a new anti-cancer treatment or are anticipated to change anti-cancer treatments are not eligible.
• Age \> 18 years
• Karnofsky performance status ≥ 60%
• Life expectancy of greater than 4 months
• Patients must have normal organ and marrow function as defined below:
• leukocytes \>3,000/mcL absolute neutrophil count \>1,500/mcL platelets \>100,000/mcL total bilirubin 1.5 X institutional upper limits of normal AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance \>50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• The effects of solriamfetol on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)

You may not qualify if:

• Receiving active radiation therapy (including patients who are within 28 days of completing radiation therapy)
• Anticipated to undergo radiation therapy or require neurosurgical intervention during the period of active treatment(i.e. within the next 4 months)
• Contraindication to solriamfetol based on drug-drug interactions or concurrent systemic illness that precludes drug treatment
• Patients who have not recovered to \< CTCAE grade 2 toxicities related to prior or current therapy are ineligible.
• Exception for laboratory-based or other adverse event that is stable and not anticipated to interfere with study related treatment must be reviewed and approved by the study chair
• Customary bedtime later than midnight
• Known and/or documented history of obstructive sleep apnea (OSA)
• Uncontrolled behavioral or psychiatric disorder (including suicidal ideation)
• Current excessive caffeine use (\> 600 mg/day or \> 6 cups of coffee/day)
• Current or prior history of alcohol or drug abuse within the last 2 years as assessed by the treating clinician
• Nicotine dependence that is currently interfering with sleep based on assessment by the treating clinician
• Concurrent use of selective serotonin or norepinephrine reuptake inhibitors (e.g. selective serotonin reuptake inhibitor \[SSRI\], serotonin and norepinephrine reuptake inhibitors \[SNRI\]) within 14 days of study enrollment
• Patients who are currently taking these agents may be tapered at the direction of the treating physician prior to study enrollment
• Patients taking other medications such as narcotics, benzodiazepines, antipsychotics, antiepileptics, corticosteroids, or over-the-counter sleep aids can be enrolled. It is recommended that the doses of these medications remain the same throughout the portion of active study treatment unless there is a medical indication for dose adjustment which will be determined by the treating physician
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to solriamfetol

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Results Point of Contact

• Title: Principal Investigator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

rstrowd@wakehealth.edu

336-716-7548

Study Officials

• Roy Strowd, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: January 27, 2021
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: August 3, 2026
• Results First Posted: October 21, 2025

Record last verified: 2026-07

Locations

US (1)