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حالة التجربة السريرية NCT05521997 لـ سرطان عنق الرحم المتقدم، سرطان عنق الرحم، سرطان عنق الرحم، سرطان عنق الرحم هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث

Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer المرحلة الثانية ٤٢

لم يبدأ القبول بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT05521997 مصممة لدراسة علاج لـسرطان عنق الرحم المتقدم، سرطان عنق الرحم، سرطان عنق الرحم، سرطان عنق الرحم. هذه تجربة تدخُّلية من المرحلة الثانية وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٧ صفر ١٤٤٨ هـ لتجنيد ٤٢ مشاركًا. تقودها جامعة واشنطن في سانت لويس، ومن المتوقع اكتمالها بحلول ٢ رجب ١٤٥٤ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٤ رمضان ١٤٤٧ هـ.
الملخص
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.
العنوان الرسمي

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

الحالات الطبية
سرطان عنق الرحم المتقدمسرطان عنق الرحمسرطان عنق الرحمسرطان عنق الرحم
معرّفات دراسة أخرى
NCT معرّف
NCT05521997
تاريخ البدء (فعلي)
2026-07-31
آخر تحديث مُنشور
2026-03-13
تاريخ الاكتمال (المقدر)
2032-10-07
عدد المشاركين المخطط لهم
٤٢
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثانية
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
advanced cervical cancer
Glutaminase Inhibitor
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
مقارن نشطControl Arm: Standard of Care Chemoradiation
-Participants will receive 7 weeks of standard of care chemoradiation.
علاج إشعاعي
* 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
تجريبيةExperimental 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
علاج إشعاعي
* 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
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
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)
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
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)
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل

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 logoجامعة واشنطن في سانت لويس462 تجارب سريرية نشطة للاستكشاف
جهة اتصال مركزية للدراسة
جهة اتصال: Julie K Schwarz, M.D., Ph.D., 314-608-6813, [email protected]
1 مواقع الدراسة في 1 بلدان

Missouri

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