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A Dose-escalation Study of BIBF 1120 in Japanese Patients With Advanced Solid Tumours

17 juillet 2014 mis à jour par: Boehringer Ingelheim

A Phase I Open-label Dose-escalation Study of Continuous Twice-daily Oral Treatment With BIBF 1120 in Japanese Patients With Advanced Solid Tumours

Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as safe and tolerable treatment in Japanese patients with advanced solid tumours, overall safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

24

Phase

  • La phase 1

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

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Male or female patients with a confirmed diagnosis of an advanced, non resectable and/or metastatic solid tumour (except for malignant lymphoma)
  2. Patients who have not responded to conventional treatment, or for whom no therapy of proven efficacy was available, or who were not amenable to established forms of treatment

  3. Patients recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radio-therapies (except for epilation) at least over the following periods of time:

    • four weeks after chemotherapy (at least 2 weeks after receiving antimetabolite or at least 6 weeks after nitrosourea or mitomycin C)
    • two weeks after receiving hormone therapy
    • four weeks after receiving radiation therapy (2 weeks after radiation for symptom control)
    • two weeks after receiving immunotherapy
    • four weeks after surgical procedures
  4. Age 20 years or older
  5. Life expectancy of at least 3 months
  6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2

  7. Patients retaining a significant physiological compensatory function and without manifest marked disorders of the hematopoietic system, heart, lung, liver, kidneys, etc., i.e., patients with sufficient baseline organ function

    • An absolute neutrophil count more than 1500/mm3
    • A platelet count more than 100000/mm3
    • A haemoglobin count more than 9.0 g/dL
    • Serum creatinine less than 1.5-fold the upper limit value of the normal range
    • Bilirubin less than 1.5-fold the upper limit value of the normal range
    • Activities of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) less than 1.5-fold the upper limit value of normal range (if related to liver metastases less than 2.5-fold the upper limit value of the normal range)
    • Saturation pulse oxygen (SpO2) level not less than 90%
  8. No participation in other clinical trials within 4 weeks before start of therapy within this trial
  9. Written informed consent given that is consistent with ICH-GCP guidelines

Exclusion criteria

  1. Brain tumour, and/or brain metastases requiring therapy
  2. History of obvious pulmonary fibrosis or interstitial pneumonitis in chest X-ray including pneumoconiosis or radiation-induced pulmonary fibrosis expanding out of radiation field
  3. Patients with difficulty in swallowing study medication
  4. Gastrointestinal disorders that might interfere with the absorption of the study drug (Crohn's disease, ulcerative colitis, broad resection of the stomach)
  5. Patients with diarrhoea greater than CTCAE grade 2
  6. Patients within 4 weeks after major surgical procedures or patients with active ulcers or with injuries with incomplete wound healing
  7. History of autoimmune disease
  8. History of serious drug hypersensitivity
  9. History of cardiac infarction or congested heart failure of New York Heart Association Classification (NYHA) II or greater within previous 6 months
  10. Serious illness or concomitant non-oncological disease difficult to be controled by medication, such as active infectious disease, hepatic failure, renal failure, pulmonary fibrosis, interstitial pneumonitis, hemorrhagic tendency, heart disease (congested heart failure, angina, arrhythmia, etc.), uncontrolled, severe hypertension, and diabetes
  11. Pregnancy or breastfeeding
  12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception until 4 weeks after the last trial visit
  13. Patients positive in tests of hepatitis B (HBs) antigen, hepatitis C (HCV)antibody, or HIV antibody
  14. Alcohol or drug abuse
  15. Patient not suitable for participation in this clinical trial in the opinion of the investigator

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: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: BIBF 1120
Médicament: BIBF 1120

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120
Délai: Up to 36 months
Up to 36 months
Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTCAE Version 3.0) associated with increasing doses of BIBF 1120
Délai: up to 36 months
up to 36 months

Mesures de résultats secondaires

Mesure des résultats
Délai
maximum tolerated dose (MTD) of BIBF 1120
Délai: Up to 36 months
Up to 36 months
Objective tumour response according to the response evaluation criteria in solid tumours (RECIST)
Délai: Up to 36 months
Up to 36 months
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours after single dose administration (AUC0-12)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the first drug administration
Change from baseline in peripheral blood biomarkers
Délai: Baseline, day 2, day 8, day 30
Baseline, day 2, day 8, day 30
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24hours after single dose administration (AUC0-24)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration after single dose administration (AUC0-tz)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration (AUC0-∞)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
The percentage of the AUCtz-∞ that is obtained by extrapolation (%AUCtz-∞)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Maximum measured concentration of the analyte in plasma following a single dose (Cmax)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Time from dosing to the maximum concentration of the analyte in plasma following a single dose (tmax)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Terminal half-life of the analyte in plasma after single dose administration (t1/2)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Terminal rate constant in plasma after single dose administration (λz)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Mean residence time of the analyte in the body after single dose oral administration (MRTpo)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Apparent clearance of the analyte in plasma after single dose extravascular administration (CL/F)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration
Area under the concentration-time curve of the analyte in plasma at steady state over the time interval from 0 to 24hours (AUC0-24,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Τime from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Terminal rate constant in plasma at steady state (λz,ss)
Délai: Up to 36 month
Up to 36 month
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Average concentration of the analyte in plasma at steady state (Cavg)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Délai: before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after drug administration
Accumulation ratio (RA)
Délai: Up to 36 month
Up to 36 month
Predose concentration of the analyte in plasma immediately before administration of the n-th dose (Cpre,n)
Délai: Day 8, 15 and day 22 after start of treatment
Day 8, 15 and day 22 after start of treatment

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 juin 2006

Achèvement primaire (Réel)

1 juin 2009

Dates d'inscription aux études

Première soumission

2 juillet 2014

Première soumission répondant aux critères de contrôle qualité

7 juillet 2014

Première publication (Estimation)

8 juillet 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

18 juillet 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juillet 2014

Dernière vérification

1 juillet 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1199.19

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