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Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)

25. marts 2014 opdateret af: Bayer

A Multicenter Uncontrolled Study of Sorafenib in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

      • Beijing, Kina, 100021
      • Shanghai, Kina, 200032
      • Shanghai, Kina, 200127
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210003
      • Tainan, Taiwan, 70428
      • Taipei, Taiwan, 112
      • Taipei, Taiwan, 10002
      • Taoyuan, Taiwan, 333

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:

  • Patients who have a life expectancy of at least 12 weeks
  • Patients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients with rare subtypes of RCC such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors are excluded from study participation.
  • Patients who have received not more than one prior systemic therapy for advanced disease which was completed at least 30 days prior to the first dose of study medication.
  • Patients who have at least one uni-dimensional measurable lesion by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST)
  • Patients with "Intermediate" or "low" risk per the Motzer score
  • Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, liver and renal function at screening as assessed by the following:
  • Total bilirubin < 1.5 x the upper limit of normal.
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer).
  • Amylase and lipase < 1.5 x the upper limit of normal.

    • Serum creatinine < 2.0 x the upper limit of normal.
    • Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal

Exclusion Criteria:

  • Previous or concurrent cancer that is distinct in primary sit or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors [Ta (Noninvasive papillary carcinoma), Tis (Carcinoma in situ: "flat tumor") and T1 (Tumor invades subepithelial connective tissue)] or any cancer curatively treated > 3 years prior to study entry)
  • Patients who completed their prior systemic treatment regimen less than 30 days
  • Cardiac arrhythmias requiring anti-arrhythmic (excluding beta blockers or digoxin), symptomatic coronary artery disease or ischemia
  • Active clinically serious bacterial or fungal infections
  • Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C requiring current interferon treatment
  • Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging studies within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
  • Patients with evidence or history of bleeding diathesis.
  • Patients with seizure disorder requiring medication
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Pregnant or breast-feeding patients.

Excluded concomitant medications:

  • Concurrent anti-cancer chemotherapy, immunotherapy, or hormonal therapy except Bisphosphonates
  • Radiotherapy during study or within 3 weeks of start of study drug.
  • Biological response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CFS) or Granulocyte macrophage colony-stimulating factor (GM-CFS), within 3 weeks prior to study entry or during study
  • Significant surgery within 4 weeks prior to start of study drug
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study
  • Investigational drug therapy during or within 4 weeks prior to first drug administration and during the study
  • St John's Wort
  • Xiao Chai Hu Tang
  • Prior and concomitant use of Bevacizumab, and all other drugs (investigational or licensed) that target Vascular Endothelial Growth Factor (VEGF)/VEGF-Receptors, Raf-kinase inhibitors (RKI), Methyl Ethyl Ketone (MEK) or Farnesyl transferase inhibitors

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
Eksperimentel: Sorafenib (Nexavar, BAY43-9006)
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])
Tidsramme: 12 hours after at least 21 days of uninterrupted dosing
The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]).
12 hours after at least 21 days of uninterrupted dosing
Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)
Tidsramme: 12 hours after at least 21 days of uninterrupted dosing
Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.
12 hours after at least 21 days of uninterrupted dosing
Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)
Tidsramme: 12 hours after at least 21 days of uninterrupted dosing
Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)].
12 hours after at least 21 days of uninterrupted dosing

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months
Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.
Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months
Overall Survival (OS)
Tidsramme: Time from start of therapy to death up to 17.25 months
Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.
Time from start of therapy to death up to 17.25 months
Time to Progression (TTP)
Tidsramme: Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months
Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months
Disease Control (DC)
Tidsramme: From start to end of study medication up to 17.25 months
The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).
From start to end of study medication up to 17.25 months
Overall Best Response
Tidsramme: Best response observed from start to end of study medication up to 17.25 months
The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.
Best response observed from start to end of study medication up to 17.25 months
Overall Response Duration
Tidsramme: From PR or CR to progression or death up to 17.25 months
Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.
From PR or CR to progression or death up to 17.25 months
Time to Objective Response
Tidsramme: Time from start of study medication to first documented PR or CR up to 17.25 months
Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.
Time from start of study medication to first documented PR or CR up to 17.25 months

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. december 2005

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. maj 2008

Datoer for studieregistrering

Først indsendt

21. december 2007

Først indsendt, der opfyldte QC-kriterier

3. januar 2008

Først opslået (Skøn)

4. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2014

Sidst verificeret

1. marts 2014

Mere information

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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