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L'essai clinique NCT05521997 pour Carcinome cervical avancé, Cancer du col de l'utérus, Cancer du col de l'utérus, Cancer du col de l'utérus est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer Phase II 42

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT05521997 est conçu pour étudier le traitement de Carcinome cervical avancé, Cancer du col de l'utérus, Cancer du col de l'utérus, Cancer du col de l'utérus. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 31 juillet 2026, avec un objectif de 42 participants. Dirigée par l'Université Washington de Saint-Louis, l'étude devrait être terminée d'ici le 7 octobre 2032. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 13 mars 2026.
Résumé succinct
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.
Titre officiel

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

Pathologies
Carcinome cervical avancéCancer du col de l'utérusCancer du col de l'utérusCancer du col de l'utérus
Autres identifiants de l'étude
Numéro NCT
NCT05521997
Date de début (réel)
2026-07-31
Dernière mise à jour publiée
2026-03-13
Date de fin (estimée)
2032-10-07
Inscription (estimée)
42
Type d'étude
Interventionnel
PHASE
Phase II
Statut
Pas encore en recrutement
Mots clés
advanced cervical cancer
Glutaminase Inhibitor
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifControl Arm: Standard of Care Chemoradiation
-Participants will receive 7 weeks of standard of care chemoradiation.
Traitement par radiation
* 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
ExpérimentalExperimental 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
Traitement par radiation
* 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
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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)
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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)
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous

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 logoUniversité Washington de Saint-Louis
Contact central de l'étude
Contact: Julie K Schwarz, M.D., Ph.D., 314-608-6813, [email protected]
1 Centres de l'étude dans 1 pays

Missouri

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