NCT03868943终止2 期
Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Proportion With Grade 3 or Higher Adverse Events
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Solriamfetol
Experimental
Given orally daily
干预措施: Soliramfetol (Drug)
结局指标
主要结局
Proportion With Grade 3 or Higher Adverse Events
时间窗: Duration of treatment (timing ranges from 3 weeks to 9 weeks past start of 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). The proportions of subjects who experienced grade 3 or above toxicities will be estimated
次要结局
- 7-day Patient-Reported Sleep Diary(Approximately 10 weeks post treatment)
- 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))
- FACT-Brain Module (FACT-Br)(End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment))
- 7 Day Actigraphy(Approximately over 10 weeks post treatment)
- 7-day Patient-Reported Sleep Diary(Approximately 10 weeks post treatment)
研究者
研究点 (1)
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