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Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

27 de junio de 2019 actualizado por: Boehringer Ingelheim

An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

542

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
  • India
      • Bangalore, India, 560052
        • Vikram Hospital
      • Bengaluru, India, 560027
        • HCG Hospital
      • Calicut, India, 673002
        • P VS Hospital Pvt Ltd
      • Chennai, India, 600031
        • V S Hospital
      • Delhi, India, 110092
        • Max Super Speciality Hospital, Delhi
      • Hyderabad, India, 500004
        • Global Hospitals
      • Hyderabad, India, 500034
        • Basavatarakam Indo - American Cancer Hospital & Research Ins
      • Jaipur, India, 302004
        • SEAROC Cancer Centre
      • Kolkata,West Bengal, India, 700053
        • B. P. Poddar Hospital & Medial Research Ltd
      • Madurai, India, 625 020
        • Asirvatham Multispeciality Hospital
      • Maharashtra, India, 422 004
        • Curie Manavata Cancer Centre
      • Maharashtra, India, 422005
        • Shatabdi Superspeciality Hospital
      • Mumbai, India, 400010
        • Prince Aly Khan Hospital
      • Pune, India, 411001
        • Ruby Hall Clinic
  • Porcelana
      • Beijing, Porcelana, 100071
        • 307 Hospital of PLA
      • Beijing, Porcelana, 100142
        • Beijing Cancer Hospital
      • Beijing, Porcelana, 100853
        • Chinese PLA General Hospital
      • Changchun, Porcelana
        • Jilin Province Cancer Hospital
      • Guangzhou, Porcelana, 510080
        • Guangdong Provincial People's Hospital
      • Hangzhou, Porcelana, 310022
        • Zhejiang Cancer Hospital
      • Linyi, Porcelana, 276002
        • Lin Yi Tumor Hospital
      • Nanjing, Porcelana, 210000
        • Jiangsu Cancer Hospital
      • Shanghai, Porcelana, 200030
        • Shanghai Chest Hospital
      • Shanghai, Porcelana, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Porcelana, 200433
        • Shanghai Pulmonary Hospital
      • Tianjin, Porcelana, 300060
        • Tianjin Medical University Cancer Institute and Hospital
  • Singapur
      • Singapore, Singapur, 169610
        • National Cancer Centre
  • Taiwán
      • Kaohsiung, Taiwán, 824
        • E-Da Hospital
      • Tainan, Taiwán, 704
        • NCKUH
      • Taipei, Taiwán, 11490
        • Tri-Service General Hospital
      • Taoyuan County, Taiwán, 333
        • Chang-Gung Memorial Hospital, Linkou

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  • locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
  • presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy
  • male or female patients age 18 years or older (For India only, male or female patients age >=18 years and <=75 years)

  • adequate organ function, defined as all of the following:

    1. Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
    2. Platelet count >75,000/mm3
    3. Serum creatinine < 1.5 times of the upper limit of normal
    4. Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
    5. Aspartate Amino Transferase (AST) and Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN). 5) Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 6) written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

Exclusion criteria:

  • prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
  • use of anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and / or gonadorelin analogues for treatment of prostate cancer permitted)

  • radiotherapy within 4 weeks prior to drug administration except as follows:

    1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
    2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  • major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical procedure including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS).
  • known hypersensitivity to afatinib or any of its excipients
  • history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of >3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
  • Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 4 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential. Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.

  • childbearing potential (see Section 4.2.3) who:

    1. are nursing or
    2. are pregnant or
    3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
  • history of or co-existing condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
  • previous or concomitant malignancies at other sites, except effectively treated nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
  • requiring treatment with any of the prohibited concomitant medications listed, that cannot be stopped for the duration of trial participation
  • known pre-existing interstitial lung disease
  • presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
  • Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
  • meningeal carcinomatosis
  • symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Afatinib
Patient will receive afatinib once daily
Droga: Afatinib
Patient will receive afatinib once daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Serious Adverse Events (SAEs)
Periodo de tiempo: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with serious adverse events (SAEs).
From first drug administration up to 28 days after last drug administration, up to 1624 days.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Symptomatic Progression (TTSP)
Periodo de tiempo: From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment. 95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
Percentage of Participants With Drug-related (Afatinib-related) Adverse Events
Periodo de tiempo: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with drug-related (afatinib-related) adverse events.
From first drug administration up to 28 days after last drug administration, up to 1624 days.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de septiembre de 2013

Finalización primaria (Actual)

6 de julio de 2018

Finalización del estudio (Actual)

6 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

25 de septiembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

26 de septiembre de 2013

Publicado por primera vez (Estimar)

1 de octubre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

27 de junio de 2019

Última verificación

1 de junio de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1200.66

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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