XL119-001 - Gallengangs- und Gallenblasenkarzinom

XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors

Rekrutierung

Die Studie ist geschlossen.

Studiendesign

Randomized, Single Blind, Active Control, Phase III

Studienziel

Primary Outcomes: To compare survival duration for XL119 and 5-FU/LV treated subjects. Secondary Outcomes: To determine time to progressive disease for XL119 and 5-FU/LV treated subjects, to evaluate clinical benefit for XL119 and 5-FU/LV treated subjects, and to assess the safety profile of XL119.

Synopsis

A Phase 3 Multicenter, Single-Blind, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery.

Einschlusskriterien

  • Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
  • 18 years or older
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
  • Willing and able to sign informed consent
  • Sexually active men and women must use an accepted and effective method of contraception
  • Women of child-bearing age must have a negative pregnancy test
  • white blood cell count (WBC) >3000/ µL, absolute neutrophil count ≥1500/µL, hemoglobin≥9.5 g/dL, platelet count ≥100,000/µL, lymphocyte count <20,000/µL, normal blood urea nitrogen (BUN), serum creatinine within 2.5 times the upper limit of normal, alanine transaminase (ALT) within 2.5 times the upper limit of normal, aspartate transaminase (AST) within 2.5 times the upper limit of normal, bilirubin <3 mg/dL

Ausschlusskriterien

  • Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
  • Unstable angina, or class III or IV New York Heart Association heart disease
  • Central nervous system metastases
  • Uncontrolled diabetes mellitus
  • Uncontrolled seizure disorder
  • Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
  • Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation
  • Pregnant or breast-feeding
  • A known history of human immunodeficiency virus (HIV) infection

ClinicalTrials

Die Studie ist bei ClinicalTrials.gov unter der Registrierungsnummer clinicaltrials.gov/show/NCT00090025 angemeldet.
Studieninformationen bei ClinicalTrials.gov

Studienassistentin

Frau Neufang, Telefon: 06131 17-6863

Studienleiter

Herr PD Dr. Stephan Kanzler
Weitere Informationen

Leiter der klinischen Prüfung

Harold Keer, MD, PhD
Exelixis, Inc., USA