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O estudo clínico NCT05521997 para Carcinoma Cervical Avançado, Câncer cervical, Câncer do colo do útero, Câncer do colo do útero está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer Fase II 42

Ainda não recrutando
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O estudo clínico NCT05521997 vai avaliar tratamento para Carcinoma Cervical Avançado, Câncer cervical, Câncer do colo do útero, Câncer do colo do útero. Este é um estudo intervencionista de Fase II. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 31 de julho de 2026, com o objetivo de incluir 42 participantes. Coordenado por a Universidade Washington em St. Louis e deve ser concluído em 7 de outubro de 2032. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de março de 2026.
Resumo
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.
Título oficial

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

Condições médicas
Carcinoma Cervical AvançadoCâncer cervicalCâncer do colo do úteroCâncer do colo do útero
Outros IDs do estudo
Número NCT
NCT05521997
Data de início (real)
2026-07-31
Última atualização postada
2026-03-13
Data de conclusão (estimada)
2032-10-07
Inscrição (estimada)
42
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Ainda não recrutando
Palavras-chave
advanced cervical cancer
Glutaminase Inhibitor
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Comparador ativoControl Arm: Standard of Care Chemoradiation
-Participants will receive 7 weeks of standard of care chemoradiation.
Tratamento de radiação
* 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
ExperimentalExperimental 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
Tratamento de radiação
* 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
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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)
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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)
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos

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 logoUniversidade Washington em St. Louis
Contato central do estudo
Contato: Julie K Schwarz, M.D., Ph.D., 314-608-6813, [email protected]
1 Locais do estudo em 1 países

Missouri

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