Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)

17 de agosto de 2026 atualizado por: GlaxoSmithKline

A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) Versus Imatinib in Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

Gastrointestinal Stromal Tumour (GIST) is a soft tissue tumour that develops in the digestive system, most often in the stomach or small intestine. It is caused by changes in certain proteins that cause the cells to grow uncontrollably. Although current treatments may be effective, tumours may stop responding over time, highlighting the need for newer options. This study is evaluating velzatinib (GSK6042981) in participants with newly diagnosed GIST that has spread or cannot be surgically removed. Velzatinib will be compared with imatinib, the standard treatment, to assess whether it can delay disease worsening and is safe and well tolerated.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

800

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Mariano Dioca
      • Ciudad Autonoma de Buenos Aire, Argentina, C1414DRK
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Guillermo Mendez
  • Canadá
    • Ontario
      • Toronto, Ontario, Canadá, M5G 2M9
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Albiruni Abdul Razak
  • China
      • Beijing, China, 100141
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Jian Li
        • Contato:
        • Contato:
  • Coréia do Sul
      • Seoul, Coréia do Sul, 03080
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Do-youn Oh
      • Seoul, Coréia do Sul, 03722
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Minkyu Jung
      • Seoul, Coréia do Sul, 138-736
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Min-Hee Ryu
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Coréia do Sul, 06351
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Jungyong Hong
  • Estados Unidos
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68130
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Kirsten Leu
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Nashat Gabrail
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37920
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Investigador principal:
          • Saikrishna Gadde
        • Contato:
  • Japão
      • Fukuoka, Japão, 812-8582
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Eiji Oki
      • Hokkaido, Japão, 060-8648
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Yoshito Komatsu
      • Kanagawa, Japão, 241-8515
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Hiroki Osumi
      • Toyama, Japão, 930-0194
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Takayuki Ando
  • Taiwan
      • Changhua, Taiwan, 500
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ruo-Han TSENG
      • Taichung, Taiwan, 404
        • Recrutamento
        • GSK Investigational Site
        • Investigador principal:
          • Li-Yuan Bai
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).
  • Has histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
  • Has not received prior systemic therapy for their metastatic and/or surgically unresectable GIST.
  • Tumor tissue must be provided to the central laboratory. Tumor tissues may be archival (preferred) or obtained from a fresh biopsy acquired for standard of care (biopsies must be collected before randomization).
  • Participants must have ≥1 target lesion (TL).
  • All participants must use adequate contraception according to local regulations throughout the study and for a specified period after the last dose of study medication (at least 30 days for velzatinib/imatinib, or 15 days for imatinib only, as applicable, or longer if local regulations specify).
  • Male participants must either be abstinent or use a male condom (with a recommendation for their female partner to use highly effective contraception). They must also refrain from donating semen.

  • Female participants must not be pregnant or breastfeeding.

    1. Those of non-childbearing potential are eligible without additional contraception.
    2. Those of childbearing potential must use an acceptable, highly effective contraceptive method and have a negative pregnancy test before starting the study. The investigator will assess their pregnancy risk.
  • Is capable of giving signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  • Has adequate organ function.

Exclusion Criteria:

  • Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
  • Has any clinically significant gastrointestinal abnormalities that may alter absorption, e.g., malabsorption syndrome or major resection of the stomach and/or bowels.
  • Has had any major surgery (minor surgical procedures such as central venous catheter placement and tumor needle biopsy are not considered major surgical procedures) within 14 days of the first dose of study treatment or participants who have not fully recovered from surgery.
  • Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant. Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: a) transplant was [>100 days] prior to screening, and b) the participant has no active infection(s) at the time of screening.
  • Has known allergy or hypersensitivity to velzatinib or imatinib, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
  • Has a history within 6 months prior of clinically significant or uncontrolled cardiac disease, unstable angina, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure [New York Heart Association,1994], or clinically significant arrhythmia not controlled by standard of care therapy, ventricular arrhythmia, cerebrovascular accident or transient ischemic attack and uncontrolled hypertension.
  • Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for ≥2 weeks before randomization are not excluded from participation
  • Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, (excluding e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy) or that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
  • Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).
  • Has any serious and/or unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.
  • Has received radiotherapy within 14 days prior to first dose of study treatment.
  • Has received any live vaccine within 30 days of randomization. Vaccination against Coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms (e.g., Emergency Use Authorization, Conditional Marketing Authorization, or Marketing Authorization Application) are not exclusionary.
  • Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before randomization.
  • Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type of medical research before signing ICF.
  • Has a positive drug/alcohol screening assessment.

  • Has a known Human immunodeficiency virus (HIV) infection and meets at least one of the following criteria:

    1. Has documented evidence of plasma HIV-1 ribonucleic acid (RNA) ≥50 c/mL within 3 months prior to or at screening. In the 3 to 12 months prior to screening, plasma HIV 1 RNA levels consistently <50 c/mL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c/mL occurred in the 3 to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR
    2. Has not had CD4 cell counts measured in the past 12 months (i.e., at least two separate measurements taken a minimum of 28 days apart, one of which must be conducted at screening); OR
    3. Has had any CD4 cell count values ≤200 cells/mm3 in the past 12 months; OR
    4. Has had one or more changes in their combination antiretroviral therapy regimen (except for switches as allowed per details provided in protocol) or has received an antiretroviral therapy regimen that is inconsistent with locally recommended guidelines during the 3 months prior to screening; OR
    5. Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening or a history of HIV-associated invasive cervical cancer; OR
    6. Has received treatment with an HIV 1 immunotherapeutic vaccine within 90 days of screening.
  • Is pregnant or breastfeeding.
  • Is unable to adhere to the protocol, including requirements for the Follow-up Period of the study.
  • Has an alanine aminotransferase (ALT) value >2.5x upper limit of normal (ULN) or (for participants with documented liver metastases/tumor infiltration) has an ALT value >5x ULN
  • Has a total bilirubin value >1.5x ULN.
  • Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
  • Evidence of chronic hepatitis B virus (HBV) infection with detectable viral load despite antiviral therapy with high resistance barrier.
  • 12-lead electrocardiogram (ECG) demonstrating mean QT interval corrected (QTc) corrected by Fridericia's formula >480msec at screening or history of long QT syndrome.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Imatinibe
Medicamento: Imatinib
Imatinib will be administered
Outros nomes:
  • GLIVEC / GLEEVEC
Experimental: Velzatinib
Medicamento: Velzatinib
Velzatinib will be administered
Outros nomes:
  • GSK6042981

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS) as assessed by Blinded independent central review (BICR)
Prazo: Up to approximately 74 months
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
Up to approximately 74 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Confirmed Objective Response Rate (ORR) as assessed by BICR
Prazo: Up to approximately 75 months
Confirmed ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response criteria.
Up to approximately 75 months
Overall survival (OS)
Prazo: Up to approximately 75 months
OS is defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 75 months
Confirmed ORR as assessed by Investigator assessment
Prazo: Up to approximately 75 months
Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR per response criteria.
Up to approximately 75 months
Time from initial study randomization to second disease progression or death (PFS2)
Prazo: Up to approximately 75 months
PFS2 is defined as the time from initial study randomization to second disease progression or death after starting the next line of treatment.
Up to approximately 75 months
PFS as assessed by Investigator assessment
Prazo: Up to approximately 75 months
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
Up to approximately 75 months
Time to Response (TTR)
Prazo: Up to approximately 75 months
TTR as assessed by BICR and investigator, is defined as time from randomization until the first documented PR or CR that was subsequently confirmed.
Up to approximately 75 months
Duration of Response (DOR)
Prazo: Up to approximately 75 months
DOR as assessed by BICR and investigator, is defined as time from the first documented PR or CR that was subsequently confirmed until the first documented PD or death due to any cause.
Up to approximately 75 months
Time to Second Subsequent Therapy (TSST)
Prazo: Up to approximately 75 months
TSST is defined as the time from the date of randomization to the earliest date of second subsequent therapy or death due to any cause.
Up to approximately 75 months
Number of participants with Treatment-emergent adverse event (TEAEs) and serious adverse event (SAEs) by severity
Prazo: Up to approximately 75 months
Up to approximately 75 months
Number of participants with TEAEs/SAEs leading to dose reductions, interruptions and treatment discontinuation
Prazo: Up to approximately 75 months
Up to approximately 75 months
Number of participants with clinically significant changes in vital signs, electrocardiograms, and clinical laboratory parameters
Prazo: Up to approximately 75 months
Up to approximately 75 months
Plasma concentration of velzatinib
Prazo: Up to approximately 75 months
Up to approximately 75 months
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Prazo: Up to approximately 75 months
The EORTC QLQ-C30 includes 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. These include functional scales, symptom scales, global health status scale, and single item scales. Scores are averaged and transformed to 0 to 100. Higher scores indicate greater functioning, better global health status, or more severe symptoms
Up to approximately 75 months
Time to confirmed deterioration (TTCD) of EORTC QLQ-C30
Prazo: Up to approximately 75 months
TTCD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration on the Physical & Role Functioning & Global Health Status/QoL scales of the EORTC QLQ-C30.
Up to approximately 75 months
Number of participants with symptomatic AEs by severity as measured by patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Prazo: Up to approximately 75 months
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicities in participants in cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
Up to approximately 75 months
Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)
Prazo: Up to approximately 75 months
The FACT GP5 is an assessment focused on the overall side effects impact to inform the tolerability of a treatment. The FACT GP5 ("I am bothered by side effects of treatment") responses are given on a 5-point Likert type scale. The response scale ranges from 0 (Not at all) to 4 (Very much). Higher scores indicate a higher degree of AE bother.
Up to approximately 75 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de julho de 2026

Conclusão Primária (Estimado)

30 de agosto de 2032

Conclusão do estudo (Estimado)

28 de setembro de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

6 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

13 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 306293
  • 2025-524934-24 (Outro identificador: EU CT Number)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever