- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00605722
A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
12. juni 2014 opdateret af: Hoffmann-La Roche
A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer
This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer.
Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks.
The anticipated time on study treatment was until disease progression, and the target sample size was <100 individuals.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
51
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Manila, Filippinerne, 1000
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Seoul, Korea, Republikken, 138-736
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Kueishan, Taiwan, 333
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Tainan, Taiwan, 704
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Taipei, Taiwan, 00112
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Taipei, Taiwan, 106
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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:
- adult patients, ≥ 18 years of age;
- advanced or metastatic liver cancer;
- ≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.
Exclusion Criteria:
- prior or concomitant systemic anti-cancer treatment for advanced disease;
- patients at high risk of variceal bleeding;
- clinically significant cardiovascular disease;
- major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.
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
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: bevacizumab + erlotinib
Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
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5 mg/kg iv on day 1 of each 2 week cycle.
150 mg orally (po) daily.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With Progression-free Survival (PFS)
Tidsramme: Week 16
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Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug.
Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.
PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Week 16
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Overall Response Rate (ORR)
Tidsramme: Event driven (median follow-up 12 months)
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ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR).
Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started.
CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.
PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.
PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Disease Control Rate (DCR)
Tidsramme: Event driven (median follow-up 12 months)
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Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST).
CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.
PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.
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Event driven (median follow-up 12 months)
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Time to Tumor Progression
Tidsramme: Event driven (median follow-up 12 months)
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Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression.
Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Progression-free Survival (PFS)
Tidsramme: Event driven (median follow-up 12 months)
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PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death.
Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Overall Survival (OS)
Tidsramme: Event driven (median follow-up 12 months)
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OS was defined as the time period in months from the start of study drug treatment to death.
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Event driven (median follow-up 12 months)
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to 107 Weeks
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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Up to 107 Weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. marts 2008
Primær færdiggørelse (Faktiske)
1. september 2010
Studieafslutning (Faktiske)
1. september 2010
Datoer for studieregistrering
Først indsendt
18. januar 2008
Først indsendt, der opfyldte QC-kriterier
18. januar 2008
Først opslået (Skøn)
31. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer i fordøjelsessystemet
- Leversygdomme
- Neoplasmer i leveren
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Erlotinib hydrochlorid
- Bevacizumab
Andre undersøgelses-id-numre
- ML21213
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 .
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