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임상시험 NCT05521997은(는) 진행된 자궁경부암, 자궁경부암, 자궁경부암, 자궁경부암에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer 2상 42

대상자모집전
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05521997은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 진행된 자궁경부암, 자궁경부암, 자궁경부암, 자궁경부암에 대해 진행되며, 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 7월 31일부터 가능하며, 42명의 참여자를 모집할 예정입니다. 워싱턴 대학교 세인트루이스이(가) 진행하는 이 연구는 2032년 10월 7일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 13일에 갱신되었습니다.
간단한 개요
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.
공식 제목

Phase II Study of Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer

질환명
진행된 자궁경부암자궁경부암자궁경부암자궁경부암
기타 연구 식별자
NCT 번호
NCT05521997
실제 연구 시작일
2026-07-31
최신 업데이트 게시
2026-03-13
예상 연구 완료일
2032-10-07
계획된 등록 인원
42
연구종류
중재연구
단계/상
2상
상태
대상자모집전
키워드
advanced cervical cancer
Glutaminase Inhibitor
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
활성 대조군Control Arm: Standard of Care Chemoradiation
-Participants will receive 7 weeks of standard of care chemoradiation.
방사선 치료
* Standard of care * External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
Cisplatin
* Standard of care * Weekly administration of cisplain
실험적Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
Telaglenastat
-800 mg twice per day by mouth
방사선 치료
* Standard of care * External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
Cisplatin
* Standard of care * Weekly administration of cisplain
주요결과변수
결과변수측정값 설명시간 범위
Progression-free survival (PFS) - experimental arm only
* 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
Through completion of follow-up (estimated to be 24 months and 9 weeks)
이차결과변수
결과변수측정값 설명시간 범위
Acute toxicity as measured by number of acute adverse events experienced by participant - experimental arm only
* Toxicity evaluation will report events according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) * Acute toxicity is defined as any toxicity occurring within 90 days from first receiving study radiotherapy or death, whatever event is observed first.
From start of chemoradiation treatment through 90 days
Late toxicity as measured by number of late adverse events experienced by participant - experimental arm only
* Toxicity evaluation will report events according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) * Late toxicities include any toxicity that is determined possibly, probably, or definitely related to treatment, within 24 months after completion of treatment.
From day 91 through 24 months after completion of chemoradiation
Overall survival (OS)
-OS is defined as the days from the start of Telaglenastat treatment to the date of death, censored at the last follow-up otherwise.
Through completion of follow-up (estimated to be 24 months and 9 weeks)
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체

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-839.
  • 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).

  • 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)
Washington University School of Medicine logo워싱턴 대학교 세인트루이스462개의 진행 중인 임상시험 탐색 가능
연구 대표 연락처
연락처: Julie K Schwarz, M.D., Ph.D., 314-608-6813, [email protected]
1 1개국에 임상시험 장소

Missouri

Washington University School of Medicine, St Louis, Missouri, 63110, United States
Julie K Schwarz, M.D., Ph.D., 연락처, 314-608-6813, [email protected]
Julie K Schwarz, M.D., Ph.D., 책임연구자
Stephanie Markovina, M.D., Ph.D., 공동연구자
Andrea Hagemann, M.D., MSCI, 공동연구자
Dineo Khabele, M.D., 공동연구자
Lindsay Kuroki, M.D., 공동연구자
L. Stewart Massad, M.D., 공동연구자
Carolyn McCourt, M.D., 공동연구자
Maggie Mullen, M.S., 공동연구자
David Mutch, M.D., 공동연구자
Matthew Powell, M.D., 공동연구자
Premal Thaker, M.D., 공동연구자
David DeNardo, Ph.D., 공동연구자
Gary Patti, Ph.D., 공동연구자
Li Ding, Ph.D., 공동연구자
Esther Lu, Ph.D., 공동연구자