- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01131689
Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma
Phase 1 Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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-
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Seoul, Korea, Republikken
- Samsung Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients with histologically confirmed hepatocellular carcinoma (HCC) or a combination of radiologically compatible finding to HCC, alpha-fetoprotein>400ng/mL and liver cirrhosis
Inoperable disease as defined by
- Localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin OR
- Presence of extra-hepatic disease OR
- Main portal vein or hepatic vein involvement (invasion or tumor thrombus) OR
- The HCC must not be amenable to intra-arterial therapy or local ablative therapy
- Minimum life expectancy of 12 weeks
- Age>18 years.
- ECOG Performance Status of 0-1
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin>9.0 g/dl
- Absolute neutrophil count (ANC) >1,500/mm3
- Platelet count > 75,000/μl
- Total bilirubin < 1.5 times the upper limit of normal
- ALT and AST <5 x upper limit of normal
- Albumin >= 3g/dL
- PT-INR/PTT <1.5 x upper limit of normal
- Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance >=50mL/min
- Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria:
- Decompensated cirrhosis or stage C according to the Child-Pugh Classification
- Chemo-embolization within 8 weeks of inclusion
- Other concomitant anticancer agent, including Tamoxifen and Interferon
- History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of HIV infection
- Active clinically serious infections (> grade 2 CTCAE version 3.0)
- Symptomatic metastatic brain or meningeal tumors
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft
- Patients with evidence or history of bleeding diathesis
- Patients undergoing renal dialysis
- Radiotherapy during study or within 4 weeks of start of study drug.
- Major surgery within 4 weeks of start of study
- Autologous bone marrow transplant or stem cell rescue within 4 months of study
- Prior exposure to the study drug.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- Patients unable to swallow oral medications.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
MTD
Tidsramme: 1 year
|
Primary objectives: 1. To determine maximal tolerated dose (MTD) of S-1 combined with fixed dose of sorafenib 400mg twice daily. Secondary objectives: 1. To evaluate toxicity profiles and dose-limiting toxicity (DLT) |
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Neoplasmer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer i leveren
- Karsinom
- Karsinom, hepatocellulært
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Proteinkinasehemmere
- Sorafenib
Andre studie-ID-numre
- 2008-10-009
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. .
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