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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 juillet 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

89

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Modèle interventionnel: Affectation parallèle

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
Médicament: Placebo
Expérimental: BIBF1120
Médicament: BIBF1120

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PFS Rate at 36 Weeks (After 9 Months)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2006

Achèvement primaire (Réel)

1 septembre 2008

Achèvement de l'étude (Réel)

1 mars 2014

Dates d'inscription aux études

Première soumission

3 juillet 2008

Première soumission répondant aux critères de contrôle qualité

3 juillet 2008

Première publication (Estimation)

4 juillet 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

15 août 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juillet 2016

Dernière vérification

1 juillet 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1199.9
  • EUDRACT2005-002427-14

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