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
|Condition or disease||Intervention/treatment||Phase|
|Glioma Glioblastoma||Drug: Soliramfetol||Phase 2|
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.
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)
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 :||Interventional|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas|
|Actual Study Start Date :||January 27, 2021|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||January 30, 2023|
Given orally daily
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).
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868943
|Contact: Ashley Fansler, RNfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator: Roy Strowd, MD|
|Principal Investigator:||Roy Strowd, MD||Wake Forest University Health Sciences|