NCT05521997尚未招募2 期
Phase II Study of Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) - experimental arm only
研究概览
简要总结
Advanced cervical cancer patients treated with standard of care (SOC) chemoradiation plus glutaminase inhibition with telaglenastat (CB-839) will have increased progression-free survival (PFS) compared to historical rates for patients receiving SOC chemoradiation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients eligible for definitive chemoradiotherapy, including brachytherapy
- •Patient age ≥ 18 years.
- •Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous, adenosquamous, adenocarcinoma or poorly differentiated); Federation of Gynecology and Obstetrics (FIGO) 2018 clinical stages III-IVA.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Absolute neutrophil count ≥ 1,500/mcL.
- •Platelets ≥ 100,000/mcL.
- •Hemoglobin ≥ 8 g/dL (can be transfused prior to study).
- •Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); patients with known Gilbert disease with serum bilirubin ≤ 3 x ULN may be enrolled.
- •Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]/alanine aminotransfersase (ALT) (serum glutamate pyruvate transaminase [SGPT] ≤ 2.5 x ULN.
- •Alkaline phosphatase ≤ 2.5 x ULN.
- •Serum creatinine ≤ 1.5 mg/dL to receive weekly cisplatin; patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no hydronephrosis and the estimated creatinine clearance (CCr) is ≥ 30 ml/min. For the purpose of estimating the CCr, formulas, including Cockcroft and Gault for females or similar, should be used.
- •International normalize ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular weight heparin or warfarin, should be on a stable dose).
- •Patient does not have uncontrolled diabetes mellitus (i.e. fasting blood glucose >200 mg/dL).
- •Patient does not have a known allergy to cisplatin or compounds of similar biologic composition as CB-
- •Patient is not actively breastfeeding (or has agreed to discontinue before the initiation of protocol therapy).
- •Ability to understand and the willingness to sign a written informed consent document.
- •Patients does not have known human immunodeficiency virus syndrome (HIV testing optional).
排除标准
- •Patient has another concurrent active invasive malignancy.
- •Patient has received prior radiation therapy to the pelvis or previous therapy of any kind for this malignancy, or pelvic radiation for any prior malignancy.
- •Patient is receiving another investigational agent for the treatment of cancer.
- •Poorly controlled diabetes, with inability to perform 18F-FDG PET scan.
- •Patient is pregnant or breastfeeding.
- •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.
- •Mean resting QTc > 470 msec obtained by electrocardiogram (ECG).
- •Severe, active co-morbidity defined as follows:
- •Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel obstruction
- •Patients who require parental hydration and/or nutrition
- •Patients who require drainage gastrostomy tube
- •Evidence of bleeding diathesis or clinically significant coagulopathy
- •Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture
- •History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment
- •Significant cardiovascular or cerebrovascular disease including: Uncontrolled hypertension (systolic blood pressure [SBP] >= 150; diastolic blood pressure [DBP] >= 90)
研究组 & 干预措施
Control Arm: Standard of Care Chemoradiation
Active Comparator
-Participants will receive 7 weeks of standard of care chemoradiation.
干预措施: Cisplatin (Drug)
Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
Experimental
-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
干预措施: Radiation treatment (Radiation)
Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
Experimental
-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
干预措施: Telaglenastat (Drug)
Control Arm: Standard of Care Chemoradiation
Active Comparator
-Participants will receive 7 weeks of standard of care chemoradiation.
干预措施: Radiation treatment (Radiation)
Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
Experimental
-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS) - experimental arm only
时间窗: Through completion of follow-up (estimated to be 24 months and 9 weeks)
* PFS is defined as the duration of time from start of telaglenastat to time of progression or death, whichever occurs first. * Progressive disease: New foci of abnormal FDG uptake not present on the pretreatment FDG-PET study
次要结局
- Overall survival (OS)(Through completion of follow-up (estimated to be 24 months and 9 weeks))
- Acute toxicity as measured by number of acute adverse events experienced by participant - experimental arm only(From start of chemoradiation treatment through 90 days)
- Late toxicity as measured by number of late adverse events experienced by participant - experimental arm only(From day 91 through 24 months after completion of chemoradiation)
研究者
研究点 (1)
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