- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00730925
Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients
24. februar 2014 oppdatert av: Boehringer Ingelheim
A Phase II Single-arm Trial of BIBW 2992 in Demographically and Genotypically Selected NSCLC
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
41
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Antwerpen, Belgia
- 1200.41.32003 Boehringer Ingelheim Investigational Site
-
Charleroi, Belgia
- 1200.41.32007 Boehringer Ingelheim Investigational Site
-
Jette, Belgia
- 1200.41.32001 Boehringer Ingelheim Investigational Site
-
Leuven, Belgia
- 1200.41.32011 Boehringer Ingelheim Investigational Site
-
Liège, Belgia
- 1200.41.32008 Boehringer Ingelheim Investigational Site
-
Namur, Belgia
- 1200.41.32006 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Badalona (Barcelona), Spania
- 1200.41.34001 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:
- patients with pathologically confirmed diagnosis of NSCLC stage IIIB/IV adeno- or bronchoalveolar carcinoma (BAC)
- non smokers patients or patients having smoked less than 15 pack years and who stopped smoking for at least one year before diagnosis (except for patients with her2-neu mutation)
- presence of activating mutation(s) in exon 18 to exon 21 of the EGFR or HER2-neu-receptor confirmed by direct DNA sequencing of NSCLC tumor tissue or increased copy number of the EGFR gene as determined by FISH analysis
- prior treatment up to 3 lines of chemotherapy except for HER2-neu patients (no restrictions) no prior EGFR TKI therapy for EGFR mutation negative and FISCH positive patients
- patients with at least one tumor lesion that can accurately be measured by CTscan or MRI in at least one dimension with long diameter to be recorded as > or equal to 20 mm using conventional techniques or > or equal to 10 mm with spiral CT scan
- male or female patient aged above or equal to 18 years
- life expectancy of at least 3 months
- written informed consents that is consistent with ICH-GCP guidelines
- ECOG performance score 0, 1 or 2
Exclusion criteria:
- more than 3 prior cytotoxic chemotherapy treatment regimen for relapsed or metastatic NSCLC, except for patients with HER2-neu mutations who may have received any prior therapy
- Any chemo-, hormone- or immunotherapy within the past 4 weeks or within less than 4 half-lives of the previous drug prior to treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant
- brain metastases which are symptomatic; patients with treated asymptomatic brain metastases are eligible with stable brain disease for at least 4 weeks without requirement for steroids or anti-epileptic therapy
- significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTCAE Grade > 2 diarrhea of any etiology at baseline
- patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
- other malignancies diagnosed within the past 5 years (other than non melanomatous skin cancer and in situ cervical cancer)
- radiotherapy within the past 2 weeks prior to treatment with the trial drug
- patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents)
- patients with known HIV, active hepatitis B or active hepatitis C
- known or suspected active drug or alcohol abuse
- women of childbearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
- pregnancy or breast feeding
- patient unable to comply with the protocol
- history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3
- Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram.
- Absolute neutrophil count (ANC) less than 1500/mm³.
- Platelet count less than 100 000 / mm³.
- Bilirubin greater than 1.5 mg / dl (>26 µmol / L, SI unit equivalent).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal).
- Serum creatinine greater than 1.5 times of the upper normal limit
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: BIBW 2992
patient to receive tablets of BIBW 2992 once a day, starting at high dose until progression of the disease
|
tablet BIBW high dose
|
Eksperimentell: BIBW 2992 + paclitaxel
patient whose disease progressed on treatment with BIBW 2992 monotherapy to receive tablet of BIBW 2992 once a day in combination with i.v.
paclitaxel 3 weekly
|
tablet BIBW 2992 in combination with i.v.
paclitaxel 3 weekly
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Best Objective Response
Tidsramme: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
|
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
|
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Disease Control (DC)
Tidsramme: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
|
Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.
|
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
|
Progression Free Survival (PFS) Time
Tidsramme: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
|
PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.
|
Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.
|
Summary of Pre-dose Concentrations of Afatnib in Plasma
Tidsramme: Day 15, 29 and 57
|
Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)
|
Day 15, 29 and 57
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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. juni 2008
Primær fullføring (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først innsendt
30. juni 2008
Først innsendt som oppfylte QC-kriteriene
7. august 2008
Først lagt ut (Anslag)
8. august 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Proteinkinasehemmere
- Paklitaksel
- Afatinib
Andre studie-ID-numre
- 1200.41
- 2008-001546-67 (EudraCT-nummer: EudraCT)
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 Karsinom, ikke-småcellet lunge
-
AHS Cancer Control AlbertaCross Cancer InstituteFullførtOmfattende Stage Small Cel Lung CancerCanada
-
Memorial Sloan Kettering Cancer CenterAktiv, ikke rekrutterendeB-celle lymfom | B-celle non-hodgkin lymfom | B Cell ALLForente stater
-
University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkAvsluttetTilbakevendende mantelcellelymfom | Refraktært mantelcellelymfom | Ann Arbor Stage I Mantelcellelymfom | Ann Arbor Stage II mantelcellelymfom | Ann Arbor Stage III Mantle Cell Lymfom | Ann Arbor Stage IV Mantle Cell LymfomForente stater
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkjentTilbakefallende / Refractory Mantle Cell Lymfom (MCL)Kina
-
BeiGeneRekrutteringMantelcellelymfom | Residiverende mantelcellelymfom | Refractory Mantle Cell Lymfom (MCL)Forente stater, Kina, Israel, Belgia, Polen, Spania, Tyrkia, Brasil, Italia, Canada, Storbritannia, Frankrike, Tyskland, Argentina, Puerto Rico
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMantelcellelymfom | Blastoid Variant Mantle Cell Lymfom | Pleomorf variant av mantelcellelymfomForente stater
-
City of Hope Medical CenterNational Cancer Institute (NCI)RekrutteringMantelcellelymfom | Blastoid Variant Mantle Cell Lymfom | Pleomorf variant av mantelcellelymfomForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeAnn Arbor stadium I grad 1 follikulært lymfom | Ann Arbor stadium I grad 2 follikulært lymfom | Ann Arbor stadium II grad 1 follikulært lymfom | Ann Arbor stadium II grad 2 follikulært lymfom | Ann Arbor Stage IV B-celle non-Hodgkin lymfom | Ann Arbor Stage I B-celle non-Hodgkin lymfom | Ann Arbor... og andre forholdForente stater
-
Xiangyang No.1 People's HospitalQingdao Haier Biotechnology Co.,Ltd.Har ikke rekruttert ennåB-celle lymfom refraktært | B-celle lymfom Tilbakevendende | NK CellKina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)FullførtAnn Arbor stadium III grad 1 follikulært lymfom | Ann Arbor stadium III grad 2 follikulært lymfom | Ann Arbor Stage III Indolent voksen non-Hodgkin lymfom | Ann Arbor Stage IV Grad 1 Follikulært lymfom | Ann Arbor Stage IV Grad 2 Follikulært lymfom | Ann Arbor Stage IV Indolent voksen non-Hodgkin... og andre forholdForente stater
Kliniske studier på BIBW2992
-
UNICANCERFullførtKarsinom, plateepitel i hode og nakkeFrankrike
-
Yonsei UniversityUkjentPlateepitelkarsinom i spiserøretKorea, Republikken
-
Center Trials & Treatment EuropeCenter Trials & TreatmentAktiv, ikke rekrutterendeIkke småcellet lungekreftGeorgia
-
BioGene Pharmaceutical Ltd.TilbaketrukketEndometriose | Endometriose Eggstokk | Endometriose, rektum | Endometriose eksternSveits
-
Boehringer IngelheimFullført
-
The Netherlands Cancer InstituteAstraZeneca; Boehringer IngelheimUkjentAfatinib og Selumetinib i avansert KRAS-mutant og PIK3CA villtype ikke-småcellet lungekreft (M14AFS)Gastrointestinale neoplasmer | Karsinom, ikke-småcellet lunge | Kolorektale neoplasmer | Neoplasmer i bukspyttkjertelenNederland
-
University of California, DavisNational Cancer Institute (NCI)FullførtStadium IIIA Ikke-småcellet lungekreft | Stadium IIIB Ikke-småcellet lungekreft | Tilbakevendende ikke-småcellet lungekarsinom | Stadium IV ikke-småcellet lungekreftForente stater
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeHematopoetisk og lymfoid celle-neoplasma | Avansert lymfom | Avansert malignt solid neoplasma | Refraktær lymfom | Ildfast malignt fast neoplasma | Refraktært myelomatoseForente stater
-
University of WashingtonFullførtAvansert malignt solid neoplasma | Tilbakevendende bukspyttkjertelkarsinom | Stage III Bukspyttkjertelkreft AJCC v6 og v7 | Tilbakevendende ondartet fast neoplasma | Stadium IVA Bukspyttkjertelkreft | Stadium IVB Bukspyttkjertelkreft | GallekanalkarsinomForente stater