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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Bordeaux cedex, Frankrig
        • 1199.16.3306A Boehringer Ingelheim Investigational Site
      • Clichy Cedex, Frankrig
        • 1199.16.3311A Boehringer Ingelheim Investigational Site
      • Clichy Cedex, Frankrig
        • 1199.16.3311B Boehringer Ingelheim Investigational Site
      • Paris, Frankrig
        • 1199.16.3312A Boehringer Ingelheim Investigational Site
      • Paris Cedex 10, Frankrig
        • 1199.16.3313A Boehringer Ingelheim Investigational Site
      • Paris Cedex 10, Frankrig
        • 1199.16.3313E Boehringer Ingelheim Investigational Site
      • Paris cedex 15, Frankrig
        • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2004

Primær færdiggørelse (Faktiske)

1. september 2009

Datoer for studieregistrering

Først indsendt

11. juli 2008

Først indsendt, der opfyldte QC-kriterier

14. juli 2008

Først opslået (Skøn)

15. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1199.16

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Neoplasmer

Kliniske forsøg med BIBF 1120

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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