Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120

24. november 2014 oppdatert av: Boehringer Ingelheim

Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

41

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Bordeaux cedex, Frankrike
        • 1199.16.3306A Boehringer Ingelheim Investigational Site
      • Clichy Cedex, Frankrike
        • 1199.16.3311A Boehringer Ingelheim Investigational Site
      • Clichy Cedex, Frankrike
        • 1199.16.3311B Boehringer Ingelheim Investigational Site
      • Paris, Frankrike
        • 1199.16.3312A Boehringer Ingelheim Investigational Site
      • Paris Cedex 10, Frankrike
        • 1199.16.3313A Boehringer Ingelheim Investigational Site
      • Paris Cedex 10, Frankrike
        • 1199.16.3313E Boehringer Ingelheim Investigational Site
      • Paris cedex 15, Frankrike
        • 1199.16.3302A Boehringer Ingelheim Investigational Site
  • Tyskland
      • Freiburg/Breisgau, Tyskland
        • 1199.16.49001 Boehringer Ingelheim Investigational Site
      • Grosshansdorf, Tyskland
        • 1199.16.49004 Boehringer Ingelheim Investigational Site
      • Tübingen, Tyskland
        • 1199.16.49008 Boehringer Ingelheim Investigational Site
      • Wiesbaden, Tyskland
        • 1199.16.49005 Boehringer Ingelheim Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.
  2. Age 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2
  4. Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)

Exclusion Criteria:

  1. Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
  2. Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120
  3. Active ulcers (gastro-intestinal tract, skin)
  4. Major injuries and surgery within the past three weeks with incomplete wound healing
  5. Hypersensitivity to BIBF 1120 or the excipients of the trial drug
  6. Known secondary malignancy requiring therapy
  7. Active infectious disease
  8. Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)
  9. Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
  10. Brain metastases requiring therapy
  11. Absolute neutrophil count less than 1,500/mm3
  12. Platelet count less than 100,000/mm3
  13. Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)
  14. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
  15. Serum creatinine greater than 2 mg/dl (> 176 µmol/L)
  16. Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
  17. Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug
  18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception
  19. Pregnancy or lactation
  20. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)
  21. Patients unable to comply with the protocol
  22. Active alcohol or drug abuse

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
Tidsramme: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
Tidsramme: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
Tidsramme: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
Tidsramme: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
Tidsramme: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
From signing the informed consent until final follow-up, up to 991 days
Difference From Baseline for Liver Enzymes
Tidsramme: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Bilirubin, Creatinine and Glucose
Tidsramme: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Haemoglobin
Tidsramme: From baseline until end of treatment, up to 991 days
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From baseline until end of treatment, up to 991 days
Difference From Baseline for Haematology and Differentials Parameters
Tidsramme: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Coagulation Parameters
Tidsramme: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Electrolytes
Tidsramme: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
From signing the informed consent until end of treatment, up to 991 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinically Relevant Abnormalities for Vital Signs
Tidsramme: From baseline until final follow-up, up to 991 days
Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
From baseline until final follow-up, up to 991 days
Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
Tidsramme: Just before drug administration every 28±7 days after day 29
Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29
Just before drug administration every 28±7 days after day 29
Unconfirmed Best Overall Response
Tidsramme: Baseline until end of treatment, up to 991 days

Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).

PD = Progressive disease.
Baseline until end of treatment, up to 991 days
Unconfirmed Best Objective Response
Tidsramme: Baseline until end of treatment, up to 991 days
Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Baseline until end of treatment, up to 991 days
Clinical Benefit
Tidsramme: Baseline until end of treatment, up to 991 days
Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).
Baseline until end of treatment, up to 991 days
Confirmed Objective Response
Tidsramme: Baseline until end of treatment, up to 991 days
Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Baseline until end of treatment, up to 991 days
Progression Free Survival
Tidsramme: First drug administration (in previous trial) until end of treatment, up to 1230 days

Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.

PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.

Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.
First drug administration (in previous trial) until end of treatment, up to 1230 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2004

Primær fullføring (Faktiske)

1. september 2009

Datoer for studieregistrering

Først innsendt

11. juli 2008

Først innsendt som oppfylte QC-kriteriene

14. juli 2008

Først lagt ut (Anslag)

15. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. desember 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. november 2014

Sist bekreftet

1. november 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1199.16

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Neoplasmer

Kliniske studier på BIBF 1120

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Bosnia & Herzegovina

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere