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Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer. (BASIL)

5. september 2013 opdateret af: Bayer

A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
  • Korea, Republikken
      • Busan, Korea, Republikken, 602-739
      • Seoul, Korea, Republikken, 138-736
      • Seoul, Korea, Republikken, 110-744
      • Seoul, Korea, Republikken, 120-752
      • Seoul, Korea, Republikken, 135-710
    • Daegu Gwang''yeogsi
      • Jung-gu, Daegu Gwang''yeogsi, Korea, Republikken, 700-721
    • Gyeonggido
      • Goyang-si, Gyeonggido, Korea, Republikken, 410-769
  • Singapore
      • Singapore, Singapore, 228510
      • Singapore, Singapore, 258499
  • Taiwan
      • Kaohsiung, Taiwan, 833
      • Tainan, Taiwan
      • Tainan, Taiwan, 736
      • Taipei, Taiwan, 100

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:

  • Male or Female age >/= 18 years of age
  • Life expectancy >/= 12 weeks
  • Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic
  • Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
  • History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
  • Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
  • Renal failure requiring hemo- or peritoneal dialysis
  • Known human immunodeficiency virus (HIV) infection
  • Known history or symptomatic metastatic brain or meningeal tumors
  • History of organ allograft.
  • History of interstitial lung disease (ILD).

  • Excluded previous therapies and medications:

    • Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy
    • Radiotherapy within 4 weeks prior to start of study treatment
    • Any other investigational agents within 4 weeks from the first dose of study treatment
    • Major surgery within 4 weeks of start of study
    • Concomitant use of strong inhibitors and strong inducers of CYP3A4

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
Medicin: BAY86-9766 MEK Inhibitor + Sorafenib
All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Disease Control Rate (DCR)
Tidsramme: From first dose of combination treatment until last tumor evaluation
From first dose of combination treatment until last tumor evaluation

Sekundære resultatmål

Resultatmål
Tidsramme
Overall Survival (OS)
Tidsramme: 1st dose of study medication to last date of follow up
1st dose of study medication to last date of follow up
Time To Progression (TTP)
Tidsramme: 1st dose of study medication until disease progression
1st dose of study medication until disease progression
Response Rate (RR)
Tidsramme: 1st dose of study medication until last tumor evaluation
1st dose of study medication until last tumor evaluation
Duration Of Response (DOR)
Tidsramme: 1st dose of study medication until last tumor evaluation
1st dose of study medication until last tumor evaluation
Safety: physical examination, vital signs, adverse events, safety lab
Tidsramme: At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT
At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT
Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)
Tidsramme: At day 1 of each cycle and within 7 day after the last treatment
At day 1 of each cycle and within 7 day after the last treatment
Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)
Tidsramme: Day -3, cycle 2 (day 1)
Day -3, cycle 2 (day 1)
Biomarkers
Tidsramme: At screening, day 1 of cycle 1 - 4, EOT
At screening, day 1 of cycle 1 - 4, EOT

Samarbejdspartnere og efterforskere

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

Sponsor

Bayer

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.

Generelle publikationer

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. december 2010

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

16. september 2010

Først indsendt, der opfyldte QC-kriterier

16. september 2010

Først opslået (Skøn)

17. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14899

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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