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Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (JAZZ)

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ClinicalTrials.gov Identifier: NCT03868943
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE March 7, 2019
First Posted Date  ICMJE March 11, 2019
Last Update Posted Date February 5, 2021
Actual Study Start Date  ICMJE January 27, 2021
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Proportion of Adverse Events [ Time Frame: Approximately 100 days post treatment ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
Proportion of Adverse Events [ Time Frame: Up to 30 days post treatment ]
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • Epworth Sleepiness Scale [ Time Frame: Approximately 10 weeks post treatment ]
    The effect of solriamfetol on patient-reported sleep using Epworth Sleepiness Scale measuring how likely participants are likely to doze off or fall asleep in certain situations, in contrast to feeling tired. Scale of 0 would never doze, 1 - slight chance of dozing, 2 - moderate chance of dozing and 3 - high chance of dozing.
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Approximately 10 weeks post treatment ]
    The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Score scale 0 - not during the past month, 1 - less than once a week, 2 - once or twice a week and 3 - three or more times a week.
  • Neurocognitive Battery Record [ Time Frame: 50-65 minutes at baseline and approximately 70 days post treatment ]
    Evaluation of attention, concentration, information processing speed, learning/memory and aspects of higher-order executive functions to be done at baseline and end of treatment only.
  • Cancer Fatigue Scale (CFS) [ Time Frame: Baseline, 30 days post treatment and approximately 70 days post treatment ]
    15-item self-administered patient-reported questionnaire exploring both overall and domain specific fatigue in cancer patients. The instrument explores three fatigue domains: physical effects of fatigue, cognitive effects, and affective issues related to cancer fatigue. To be completed at baseline, fixed dose initiation visit and end of treatment. Score is measured 1 - No, 2 - a little, 3 - somewhat, 4 considerably and 5 - very much.
  • Beck's Depression Inventory (BDI) [ Time Frame: Baseline, 30 days post treatment and approximately 70 days post treatment ]
    A self-scored questionnaire to assess levels of depression. Score 1-40, with 40 being severe depression and any score over 40 being extreme depression.
  • FACT-Brain module (FACT-Br) [ Time Frame: Baseline, 30 days post treatment and approximately 70 days post treatment ]
    An instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales (physical well being, social/family well being, emotional well being, functional well being and additional concerns) Scores 0 - not all all, 1 - a little bit, 2 - somewhat - 3 - quite a bit and 4 - very much. To be completed at baseline, fixed dose initiation visit and end of treatment.
  • 7 day Actigraphy [ Time Frame: Approximately over 10 weeks post treatment ]
    Actigraph devices are worn on the wrist for 7 days and record movements that can be used to estimate sleep patterns using specialized computer software programs. Completion of actigraphy will be done from baseline to end of treatment and recorded with the sleep-diary data.
  • 7-day Patient-Reported Sleep Diary [ Time Frame: Approximately 10 weeks post treatment ]
    Participants will be provided a sleep diary at the time of consent and/or study enrollment. All sleep diaries will be collected over 7-days including at pre-study baseline, throughout each dose of the dose escalation phase, and during the first 7-days and last 7-days of the fixed dose drug continuation phase of the study. Caregivers may complete sleep diaries for patients.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • Epworth Sleepiness Scale [ Time Frame: Up to 30 days post treatment ]
    The effect of solriamfetol on patient-reported sleep using Epworth Sleepiness Scale measuring how likely participants are likely to doze off or fall asleep in certain situations, in contrast to feeling tired. Scale of 0 would never doze, 1 - slight chance of dozing, 2 - moderate chance of dozing and 3 - high chance of dozing.
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Up to 30 days post treatment ]
    The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Score scale 0 - not during the past month, 1 - less than once a week, 2 - once or twice a week and 3 - three or more times a week.
  • Neurocognitive Battery Record [ Time Frame: 50-65 minutes ]
    Evaluation of attention, concentration, information processing speed, learning/memory and aspects of higher-order executive functions to be done at baseline and end of treatment only.
  • Cancer Fatigue Scale (CFS) [ Time Frame: Up to 30 days post treatment ]
    15-item self-administered patient-reported questionnaire exploring both overall and domain specific fatigue in cancer patients. The instrument explores three fatigue domains: physical effects of fatigue, cognitive effects, and affective issues related to cancer fatigue. To be completed at baseline, fixed dose initiation visit and end of treatment. Score is measured 1 - No, 2 - a little, 3 - somewhat, 4 considerably and 5 - very much.
  • Beck's Depression Inventory (BDI) [ Time Frame: Up to 30 days post treatment ]
    A self-scored questionnaire to assess levels of depression. Score 1-40, with 40 being severe depression and any score over 40 being extreme depression.
  • FACT-Brain module (FACT-Br) [ Time Frame: Approximately over 10 weeks ]
    An instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales (physical well being, social/family well being, emotional well being, functional well being and additional concerns) Scores 0 - not all all, 1 - a little bit, 2 - somewhat - 3 - quite a bit and 4 - very much. To be completed at baseline, fixed dose initiation visit and end of treatment.
  • 7 day Actigraphy [ Time Frame: Approximately over 10 weeks ]
    Actigraph devices are worn on the wrist for 7 days and record movements that can be used to estimate sleep patterns using specialized computer software programs. Completion of actigraphy will be done from baseline to end of treatment and recorded with the sleep-diary data.
  • 7-day Patient-Reported Sleep Diary [ Time Frame: Approximately 10 weeks ]
    Participants will be provided a sleep diary at the time of consent and/or study enrollment. All sleep diaries will be collected over 7-days including at pre-study baseline, throughout each dose of the dose escalation phase, and during the first 7-days and last 7-days of the fixed dose drug continuation phase of the study. Caregivers may complete sleep diaries for patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma
Official Title  ICMJE Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas
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).
Detailed Description

Primary Objective:

I. To estimate the safety of solriamfetol at 75 mg daily, 150 mg daily, 300 mg daily as assessed by NCI CTC Adverse Events (v5.0) in patients with primary gliomas compared to prior studies.

Secondary Objective(s):

I. To estimate the effect of solriamfetol on sleep by Epworth Sleepiness Scores (ESS) scores in patients with primary gliomas and compare the effect to previously published scores in patients with OSA

II. To estimate the effect of solriamfetol on sleep quality by Pittsburgh Sleep Quality Index scores

III. To estimate the effect of solriamfetol on neurocognitive function based on a disease-specific neurocognitive battery (see neurocognitive battery below)

IV. To estimate the effect of solriamfetol on patient-reported fatigue (Brief Fatigue Inventory, Cancer Fatigue Scale) & mood (Beck's Depression Inventory)

V. To estimate the effect of solriamfetol on patient-reported QOL (FACT-Br)

VI. To estimate the effect of solriamfetol on objective sleep-wake times by actigraphy and sleep diary (pre- vs post-treatment)

Exploratory Objective(s)

I. To explore a biologic gradient effect of increasing doses of solriamfetol on actigraphy

II. To explore differences in clinical activity of solriamfetol by corticosteroid use, antiepileptic use, and tumor grade.

OUTLINE: This is a dose-escalation study.

Patients receive solriamfetol orally (PO) once daily (QD) for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Glioma
  • Glioblastoma
Intervention  ICMJE Drug: Soliramfetol
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).
Study Arms  ICMJE Experimental: Solriamfetol
Given orally daily
Intervention: Drug: Soliramfetol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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)

Exclusion Criteria:

  • 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
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with solriamfetol, breastfeeding should be discontinued if the mother is treated with solriamfetol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashley Fansler, RN 336-713-3539 arcarrol@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03868943
Other Study ID Numbers  ICMJE IRB00056700
NCI-2019-01299 ( Registry Identifier: National Cancer Institute )
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU 98418 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Roy Strowd, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP