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A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

13 de julio de 2016 actualizado por: Boehringer Ingelheim
The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

89

Fase

  • Fase 2

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

  • Reino Unido
      • Burton on Trent, Reino Unido
        • 1199.9.4413 Boehringer Ingelheim Investigational Site
      • Cambridge, Reino Unido
        • 1199.9.4412 Boehringer Ingelheim Investigational Site
      • Creigiau, Cardiff, Reino Unido
        • 1199.9.4407 Boehringer Ingelheim Investigational Site
      • Leeds, Reino Unido
        • 1199.9.4410 St James's University Hospital
      • London, Reino Unido
        • 1199.9.4401 Boehringer Ingelheim Investigational Site
      • London, Reino Unido
        • 1199.9.4404 Boehringer Ingelheim Investigational Site
      • London, Reino Unido
        • 1199.9.4409 Boehringer Ingelheim Investigational Site
      • London, Reino Unido
        • 1199.9.4411 Boehringer Ingelheim Investigational Site
      • Manchester, Reino Unido
        • 1199.9.4406 Boehringer Ingelheim Investigational Site
      • Northwood, Reino Unido
        • 1199.9.4402 Boehringer Ingelheim Investigational Site
      • Sutton, Reino Unido
        • 1199.9.4405 Boehringer Ingelheim Investigational Site

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

Femenino

Descripción

Inclusion Criteria:

  • Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
  • Treatment-free interval of < 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
  • Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
  • Age > 18 years.
  • Life expectancy of at least 3 months.
  • ECOG Performance Score < 2.
  • Adequate hepatic function: total bilirubin 26µmol/L, ALT and/or AST 1.5x upper limit of normal (ULN). INR, Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits.
  • Adequate renal function: serum creatinine 1.5 x ULN.
  • Absolute neutrophil count (ANC) >1.5 x 109l, Platelets > 100 x 109/l, Haemoglobin > 9.0 g/dl.
  • Written informed consent consistent with ICH-GCP guidelines.
  • Minimum time elapsed since last chemotherapy (including hormonal treatment other than Hormone Replacement Therapy [HRT]) or immunotherapy and the first administration of BIBF 1120 must be more than 4 but less than 8 weeks.

Exclusion Criteria:

  • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
  • Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
  • Hypersensitivity to BIBF 1120 or the excipients of the study drug.
  • Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II).
  • History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
  • Patients who require full-dose anticoagulation.
  • Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug.
  • Brain metastases or leptomeningeal disease.
  • Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial.
  • Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug.
  • Patients unable to comply with the protocol.
  • Active alcohol or drug abuse.
  • Other documented malignancy with the exception of non-melanomatous skin cancer within the past 5 years.
  • Patients who are not clinically sterile.

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: Prevención
  • Modelo Intervencionista: Asignación paralela

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Droga: Placebo
Experimental: BIBF1120
Droga: BIBF1120

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PFS Rate at 36 Weeks (After 9 Months)
Periodo de tiempo: 36 weeks (after 9 months)
The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.
36 weeks (after 9 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
Periodo de tiempo: 12 weeks (after 3 months) and 24 weeks ( after 6 months)
The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.
12 weeks (after 3 months) and 24 weeks ( after 6 months)
Time to Tumour Progression
Periodo de tiempo: 9 months

Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.

For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:

Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.

Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD.
9 months
Time to Death
Periodo de tiempo: 9 months
This end point was not determined as no patients died during the trial.
9 months
Incidence and Intensity of Adverse Events With Grading According CTCAE
Periodo de tiempo: First drug administration until 28 days after last drug administration,up until 309 days
Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
First drug administration until 28 days after last drug administration,up until 309 days
Clinical Relevant Abnormalities for Laboratory Parameters
Periodo de tiempo: First drug administration until 28 days after last drug administration, up until 309 days
Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
First drug administration until 28 days after last drug administration, up until 309 days

Colaboradores e Investigadores

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

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

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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

1 de marzo de 2006

Finalización primaria (Actual)

1 de septiembre de 2008

Finalización del estudio (Actual)

1 de marzo de 2014

Fechas de registro del estudio

Enviado por primera vez

3 de julio de 2008

Primero enviado que cumplió con los criterios de control de calidad

3 de julio de 2008

Publicado por primera vez (Estimar)

4 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de agosto de 2016

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

13 de julio de 2016

Última verificación

1 de julio de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1199.9
  • EUDRACT2005-002427-14

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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