- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01346540
A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.
LUME-Lung 3: A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology
The LUME-Lung3 study is in 2 parts:
Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin.
Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2 previous courses of the chemotherapy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Barcelona, España
- 1199.82.3401 Boehringer Ingelheim Investigational Site
-
Madrid, España
- 1199.82.3406 Boehringer Ingelheim Investigational Site
-
Málaga, España
- 1199.82.3410 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Milano, Italia
- 1199.82.39004 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Maastricht, Países Bajos
- 1199.82.3102 Boehringer Ingelheim Investigational Site
-
-
-
-
-
London, Reino Unido
- 1199.82.4401 Boehringer Ingelheim Investigational Site
-
Manchester, Reino Unido
- 1199.82.4402 Boehringer Ingelheim Investigational Site
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
Run-in Phase I
- Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent Non Small Cell Lung Cancer (NSCLC) with squamous cell histology.
- Measurable disease according to Response Evaluation Criteria in Solid Tumours ( RECIST 1.1).
- Patient Eastern Cooperative Oncology Group (ECOG) score of 0-1.
- Male or female patients age = 18 years.
- Life expectancy of at least three (3) months.
Written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
Phase II - in addition to the above criteria:
- Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy.
Exclusion criteria:
- Prior therapy for advanced or metastatic or recurrent Non Small Cell Lung Cancer (NSCLC). One prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
- Prior treatment with other Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitors (other than bevacizumab)
- Any contraindications for treatment with gemcitabine and/or cisplatin.
- Use of any investigational drug within 4 weeks of entering the 1199.82 study.
- History of major thrombotic or clinically relevant bleeding event in the past 6 months.
- Significant cardiovascular diseases (i.e. hypertension not controlled by medication.
- Surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
- Active brain metastases
- Radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
- Any other current malignancy or malignancy diagnosed within the past five (5) years.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: BIBF 1120
VEGF inhibitor
|
Inhibidor de VEGF
|
Comparador de placebos: Placebo
BIBF 1120 placebo
|
BIBF 1120 placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
Periodo de tiempo: Up to 21 days from first drug administration
|
The following drug-related adverse events (AEs) qualified as a DLT: Non-hematological toxicity - Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 events excluding transient electrolyte abnormality, hyperuricemia and isolated elevation of gamma-glutamyl trans-peptidase.
Gastrointestinal AEs (nausea, vomiting, diarrhoea, abdominal pain) or hypertension of CTCAE Grade ≥3 despite optimal supportive care/intervention.
Alanine aminotransferase and or Aspartate aminotransferase elevation of CTCAE Grade ≥3.
Haematological toxicity - Uncomplicated CTCAE Grade 4 neutropenia (that was not associated with fever of ≥38.5°
Celsius) for >7 days (except during Cycle 1).
CTCAE Grade 4 febrile neutropenia associated with fever ≥38.5º
Celsius.
A decrease in platelet levels to CTCAE Grade 4 or CTCAE Grade 3 associated with bleeding or requiring transfusion.
The inability to resume nintedanib dosing within 14 days of stopping due to a drug-related AE was also considered a DLT.
|
Up to 21 days from first drug administration
|
Maximum Tolerated Dose (MTD) of Nintedanib Added to Cisplatin/Gemcitabine Based on the Occurrence of DLTs During Treatment Cycle 1.
Periodo de tiempo: Up to 21 days from first drug administration
|
The MTD was defined as the dose of nintedanib administered with gemcitabine/cisplatin at which no more than 1 of 6 patients experienced DLT (or one dose tier below that dose at which 2 or more of 6 patients experienced DLT) during the first 21-day treatment cycle.
Any DLTs experienced after the start of the second treatment period were considered separately.
|
Up to 21 days from first drug administration
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00
Periodo de tiempo: From the first drug administration until 28 days after last study drug administration, up to 804 days
|
Incidence of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 with grade 1-5.
|
From the first drug administration until 28 days after last study drug administration, up to 804 days
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Nintedanib
Otros números de identificación del estudio
- 1199.82
- 2010-019707-32 (Número EudraCT: EudraCT)
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. .
Ensayos clínicos sobre Carcinoma de pulmón de células no pequeñas
-
Adelphi Values LLCBlueprint Medicines CorporationTerminadoLeucemia de mastocitos (LCM) | Mastocitosis Sistémica Agresiva (ASM) | SM w Asoc Clonal Hema Non-mast Cell Linage Disease (SM-AHNMD) | Mastocitosis sistémica latente (MSS) | Mastocitosis Sistémica Indolente (ISM) Subgrupo ISM Completamente ReclutadoEstados Unidos
Ensayos clínicos sobre BIBF 1120
-
Boehringer IngelheimTerminadoCarcinoma de pulmón de células no pequeñasJapón
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminadoCarcinoma de cuerpo uterino recidivante | Adenocarcinoma de células claras endometriales | Adenocarcinoma seroso endometrial | Carcinoma indiferenciado de endometrio | Adenocarcinoma endometrial | Carcinoma de células de transición de endometrio | Adenocarcinoma Mucinoso Endometrial | Carcinoma de... y otras condicionesEstados Unidos
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Boehringer IngelheimTerminadoCáncer de pulmón de células no pequeñas recidivante | Cáncer de pulmón de células no pequeñas en estadio IV | Cáncer de pulmón de células escamosas | Cáncer de pulmón de células no pequeñas en estadio IIIEstados Unidos
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)TerminadoMesotelioma pleural maligno recurrente | Mesotelioma pleural en estadio IVEstados Unidos
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Boehringer Ingelheim; National Comprehensive Cancer...TerminadoCarcinoma de colon recurrente | Carcinoma rectal recurrente | Adenocarcinoma rectal | Adenocarcinoma de colon | Cáncer de colon en estadio IVA | Cáncer de recto en estadio IVA | Cáncer de colon en estadio IVB | Cáncer de recto en estadio IVBEstados Unidos
-
Boehringer IngelheimTerminadoNeoplasias prostáticas
-
Boehringer IngelheimTerminado
-
University College, LondonBoehringer IngelheimTerminadoCáncer de ovarios | Cáncer de trompa de FalopioReino Unido
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkTerminadoTumor carcinoide | Neoplasia Neuroendocrina | Tumor carcinoide metastásicoEstados Unidos