Sac-TMT in Salivary Gland Cancers (Saint-Tropez)
Phase 2 Study of Sacituzumab Tirumotecan (Sac-TMT) in Salivary Gland Cancers - Saint-Tropez (LACOG 1824) Trial
This is a Phase 2, open-label, non-randomized, parallel, two-cohort study evaluating the efficacy and safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) monotherapy in patients with advanced, recurrent, or metastatic salivary gland carcinomas who have received no more than 3 prior non-curative systemic treatment regimens. The study evaluates the activity of Sac-TMT separately in two independent cohorts based on tumor histology: Cohort 1 for Adenoid Cystic Carcinoma (ACC) and Cohort 2 for Non-Adenoid Cystic Carcinoma (non-ACC).
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Malignant salivary gland neoplasms are rare and heterogeneous malignancies with limited systemic treatment options and no widely established standard-of-care in advanced settings. Trophoblast cell surface antigen 2 (TROP-2) is broadly expressed in epithelial salivary gland carcinomas, making it a promising therapeutic target. Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2 coupled with a topoisomerase 1 inhibitor payload (KL610023).
This study aims to evaluate the clinical activity, safety, and patient-reported outcomes of Sac-TMT in two parallel, non-comparative cohorts:
Cohort 1: Patients with advanced/metastatic Adenoid Cystic Carcinoma (ACC). Cohort 2: Patients with advanced/metastatic Non-Adenoid Cystic Carcinoma (non-ACC).
Participants receive Sac-TMT at a dose of 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles (approximately 1 year), or until disease progression, unacceptable toxicity, or withdrawal of consent. The primary objective is to evaluate the Objective Response Rate (ORR) according to RECIST 1.1 in each cohort. Secondary objectives include assessment of ORR by Independent Central Review (ORR-ICR), Disease Control Rate (DCR), Duration of Response (DoR), Progression-Free Survival (PFS), 6- and 12-month PFS, Overall Survival (OS), safety and tolerability, compliance, post-progression therapies, and Patient-Reported Outcomes (EORTC QLQ-C30 and EORTC QLQ-H&N43). Exploratory research will assess ctDNA dynamics and potential predictive/resistance biomarkers in baseline and serial blood and tissue samples.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Head of Clinical Operations
- Número de telefone: +55 (51) 3384.5334
- E-mail: laura.voelcker@lacog.group
Estude backup de contato
- Nome: Project Manager
- Número de telefone: +55 (51) 3384.5334
- E-mail: lacog1824@lacog.group
Locais de estudo
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Ceará
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Fortaleza, Ceará, Brasil, 60335-480
- CRIO - Centro Regional Integrado de Oncologia
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Contato:
- Amanda Lima Sena
- E-mail: tarcilo.crio@gmail.com
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Investigador principal:
- Iane Pinto Figueiredo Lima
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 40050-410
- Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
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Investigador principal:
- Daniel Brito
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Contato:
- Nivana Borges do Sacramento
- Número de telefone: +557122038476
- E-mail: nivana.sacramento@santacasaba.org.br
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Federal District
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Brasília, Federal District, Brasil, 70710-904
- CETTRO - Centro de Câncer de Brasília (Onco Vida - Oncoclínicas)
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Contato:
- Jade Tayline Boscolo de Aragao
- Número de telefone: +556130276200
- E-mail: jade.aragao@oncoclinicas.com
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Investigador principal:
- Janice Rodrigues Farias
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INCA - Instituto Nacional de Câncer
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Rio de Janeiro, INCA - Instituto Nacional de Câncer, Brasil, 20230-130
- INCA - Instituto Nacional de Câncer
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Contato:
- Luana Aguiar Mesquita Cerva
- Número de telefone: +552132076569
- E-mail: luana.cerva@inca.gov.br
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Investigador principal:
- Daniel Gonçalves Kischinhevsky
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30360-680
- Oncocentro de Minas Gerais (Oncoclínicas)
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Contato:
- Thayara Christi Soares
- Número de telefone: +5531998266045
- E-mail: thayara.soares@oncoclinicas.com
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Investigador principal:
- Aline Lauda Freitas Chaves
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Paraná
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Londrina, Paraná, Brasil, 86015-520
- HCL - Hospital do Câncer de Londrina
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Contato:
- Elaine Lins
- Número de telefone: +5543991069442
- E-mail: pesquisa.elainecbc@hcl.org.br
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Investigador principal:
- Mariana Lopes Zanatta
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59062-000
- Liga Norte Riograndense Contra o Câncer
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Contato:
- Ana Paula Ferreira Costa
- Número de telefone: +558440095595
- E-mail: anapaula.costa@liga.org.br
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Investigador principal:
- Andrea Juliana Pereira de Santana Gomes
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90050-170
- ISCMPA - Santa Casa de Porto Alegre
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Contato:
- Igor Cesar Santos de Miranda
- E-mail: igor.miranda@santacasa.org.br
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Investigador principal:
- Jamille Rizzardi Lava
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasil, 22250-905
- CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)
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Contato:
- Thamires Cristine de Souza Castro Almeida
- Número de telefone: +5521974680316
- E-mail: thamires.almeida@oncoclinicas.com
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Investigador principal:
- Marina Xavier Reis
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Santa Catarina
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Lages, Santa Catarina, Brasil, 88501-001
- ANIMI - Unidade de Tratamento Oncológico
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Contato:
- Mariane Cabral
- E-mail: mariane.animi@gmail.com
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Investigador principal:
- Maitê de Liz Vassen Schurmann
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São Paulo
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Barretos, São Paulo, Brasil, 14784-400
- Hospital de Amor de Barretos
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Contato:
- Pedro Gabriel França Santos
- Número de telefone: +551733216637
- E-mail: pedro.santos@hospitaldeamor.com.br
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Investigador principal:
- Flávio Augusto Ferreira da Silva
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Campinas, São Paulo, Brasil, 13083-881
- Universidade Estadual de Campinas (UNICAMP)
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Contato:
- Elcio dos Santos
- Número de telefone: +5519998171210
- E-mail: elcioss@unicamp.br
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Investigador principal:
- Lígia Traldi Macedo
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São Paulo, São Paulo, Brasil, 01509-001
- A.C. Camargo Cancer Center
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Contato:
- Arianni Di Petta
- Número de telefone: +5511979985081
- E-mail: arianni.petta@accamargo.org.br
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Investigador principal:
- Thiago Bueno de Oliveira
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São Paulo, São Paulo, Brasil, 01246-000
- ICESP - Instituto do Câncer do Estado de São Paulo
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Investigador principal:
- Milena Perez Mak
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Contato:
- Erika Assis Rodrigues
- Número de telefone: +551138933555
- E-mail: erika.arodrigues@hc.fm.usp.br
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São Paulo, São Paulo, Brasil, 04538-135
- CPO - Centro Paulista de Oncologia (Oncoclínicas)
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Contato:
- Maraisa Cristina da Costa
- Número de telefone: +11971445373
- E-mail: maraisa.costa@oncoclinicas.com
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Investigador principal:
- Nathalia Gimenes
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Provided written informed consent for the study (or prescreening phase, as applicable).
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Histologically- or cytologically confirmed diagnosis of malignant salivary gland neoplasm (assessed by central pathology):
- Cohort 1: Adenoid cystic carcinoma (ACC) of the salivary gland.
- Cohort 2: Non-adenoid cystic carcinoma (non-ACC) of the salivary gland.
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Advanced disease, defined as locally advanced or recurrent disease not amenable to curative treatment, and/or metastatic disease.
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Documented disease progression within 6 months prior to enrollment.
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Received no more than 3 prior lines of non-curative intent systemic treatment regimens. Note: Patients with salivary duct carcinoma must have been tested for HER2 status; if HER2 positive (IHC 3+ or gene amplified), prior HER2-targeted therapy is required.
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Measurable disease as defined by RECIST v1.1.
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Aged 18 years or older at the time of signing informed consent.
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ECOG Performance Status of 0 or 1.
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Adequate organ function within 14 days prior to treatment initiation:
- Absolute Neutrophil Count (ANC) >= 1,500/uL;
- Platelets >= 100,000/uL;
- Hemoglobin >= 9.0 g/dL (without transfusion or growth factor support within 2 weeks);
- Measured or calculated creatinine clearance >= 30 mL/min;
- Total bilirubin <= 1.5 x ULN (or direct bilirubin < ULN for total bilirubin > 1.5 x ULN);
- AST and ALT <= 2.5 x ULN (<= 5 x ULN if liver metastases present);
- Serum albumin >= 3.0 g/dL (without albumin transfusion within 72 hours);
- INR/PT/aPTT <= 1.5 x ULN (unless receiving therapeutic anticoagulation).
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Provision of archival FFPE tumor tissue sample or fresh biopsy.
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Recovery from adverse events due to prior anticancer therapies to Grade <= 1 or baseline.
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Participants with treated HIV, HBV, or HCV are eligible if meeting protocol-specified antiviral stability and disease control parameters.
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Adherence to protocol-specified contraceptive requirements for male participants and participants of childbearing potential.
Exclusion Criteria:
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Uncontrolled or significant cardiovascular or cerebrovascular disease within 6 months prior to first dose (e.g., NYHA Class III/IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF > 480 ms).
- Prior treatment with a TROP2-targeted ADC or a topoisomerase 1 inhibitor-containing ADC.
- Systemic anticancer therapy within 2 weeks before the first dose of study intervention.
- Radiotherapy within 7 days before the first dose (except <= 10 fractions of palliative radiotherapy for non-CNS disease).
- Administration of a live or live-attenuated vaccine within 30 days before the first dose.
- Current use of strong CYP3A4 inducers or inhibitors requiring a 2-week washout prior to enrollment.
- Concurrent enrollment in another therapeutic clinical trial.
- Receipt of an investigational agent or device within 4 weeks before the first dose.
- History of additional active malignancy within the past 3 years (except adequately treated non-melanoma skin cancer, carcinoma in situ, or low-risk prostate cancer).
- Active, untreated, or unstable CNS metastases and/or carcinomatous meningitis.
- Active infection requiring systemic therapy.
- Severe hypersensitivity (Grade >= 3) to study intervention or its excipients.
- Major surgery or significant traumatic injury within 4 weeks before the first dose.
- History of noninfectious pneumonitis/ILD requiring steroids or current clinically meaningful pneumonitis/ILD.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: Cohort 1: Adenoid Cystic Carcinoma (ACC)
Participants with advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC) of the salivary gland who have received no more than three prior non-curative systemic treatment regimens. Participants receive Sacituzumab Tirumotecan (Sac-TMT) monotherapy at 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles, or until disease progression, unacceptable toxicity, or withdrawal of consent. |
Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2. Administered via intravenous (IV) infusion at a dose of 4 mg/kg on Days 1 and 15 of each 28-day cycle for up to 12 cycles.
Outros nomes:
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Experimental: Cohort 2: Non-Adenoid Cystic Carcinoma (Non-ACC)
rticipants with advanced, recurrent, or metastatic non-adenoid cystic carcinoma (non-ACC) of the salivary gland who have received no more than three prior non-curative systemic treatment regimens. Participants receive Sacituzumab Tirumotecan (Sac-TMT) monotherapy at 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles, or until disease progression, unacceptable toxicity, or withdrawal of consent. |
Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2. Administered via intravenous (IV) infusion at a dose of 4 mg/kg on Days 1 and 15 of each 28-day cycle for up to 12 cycles.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Objective Response Rate (ORR) in Cohort 1 (ACC)
Prazo: Up to 12 cycles (approximately 12 months).
|
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 in the Adenoid Cystic Carcinoma cohort. |
Up to 12 cycles (approximately 12 months).
|
|
Objective Response Rate (ORR) in Cohort 2 (Non-ACC)
Prazo: Up to 12 cycles (approximately 12 months).
|
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 in the Non-Adenoid Cystic Carcinoma cohort. |
Up to 12 cycles (approximately 12 months).
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective Response Rate by Independent Central Review (ORR-ICR)
Prazo: From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
|
Percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) as determined by an Independent Central Review (ICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
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Disease Control Rate (DCR)
Prazo: From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
|
Percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
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Duration of Response (DoR)
Prazo: From first documented response until disease progression or death, assessed up to 40 months.
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Time from the first documented objective response (complete response [CR] or partial response [PR]) to the date of first documented disease progression according to RECIST v1.1 or death due to any cause, evaluated in responders only. |
From first documented response until disease progression or death, assessed up to 40 months.
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Progression-Free Survival (PFS)
Prazo: From treatment initiation until disease progression or death, assessed up to 40 months.
|
Time from treatment initiation to first documented disease progression according to RECIST v1.1 (as evaluated by investigator assessment) or death due to any cause, whichever occurs first. |
From treatment initiation until disease progression or death, assessed up to 40 months.
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6-Month Progression-Free Survival (6-Month PFS)
Prazo: At 6 months.
|
Percentage of participants alive and progression-free at 6 months after enrollment according to RECIST v1.1, estimated using the Kaplan-Meier method. |
At 6 months.
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12-Month Progression-Free Survival (12-Month PFS)
Prazo: At 12 months.
|
Percentage of participants alive and progression-free at 12 months after enrollment according to RECIST v1.1, estimated using the Kaplan-Meier method. |
At 12 months.
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Overall Survival (OS)
Prazo: From treatment initiation until death, assessed up to 40 months.
|
Time from treatment initiation to death from any cause. |
From treatment initiation until death, assessed up to 40 months.
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
Prazo: From baseline through 30 days after the last dose of study treatment (approximately 13 months).
|
Number of participants with treatment-emergent adverse events (TEAEs) of any grade and Grade 3 or higher, characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). |
From baseline through 30 days after the last dose of study treatment (approximately 13 months).
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Change From Baseline in Health-Related Quality of Life Using EORTC QLQ-C30
Prazo: Baseline, every 6 weeks up to 24 weeks.
|
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire includes functional scales, symptom scales, and a global health status/QoL scale. All domain and item scores are linearly transformed to a 0 to 100 scale. For functional scales and global health status, higher scores represent better quality of life and higher level of functioning. For symptom scales, higher scores represent greater symptom burden/severity. |
Baseline, every 6 weeks up to 24 weeks.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: William Nassib William Junior, CPO - Centro Paulista de Oncologia (Oncoclínicas)
- Investigador principal: Aline Lauda Freitas Chaves, Oncocentro de Minas Gerais (Oncoclínicas)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- LACOG 1824
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