NCT00437424 Brivanib Clinical Trial

A NCT00437424 Brivanib Clinical Trial is a clinical trial for Brivanib.

• Context:
  • It can have ClinicalTrials.org ID: NCT00437424 [1].
  • …
• See: Liver Cancer.

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References

• https://clinicaltrials.gov/ct2/show/NCT00437424

2017

• FDA. (2017). "22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results."
  • QUOTE: ... To treat those patients who do not respond to sorafenib or who have severe side effects related to the drug, brivanib was developed. Brivanib inhibits a novel growth factor, in addition to those growth factors targeted by sorafenib. ...

    ... Several phase 3 RCTs designed to isolate the effects of brivanib, confirmed statistically significant antitumor activity, but found no evidence that treatment with brivanib improves the overall survival of patients with HCC. ...

2007

• "A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction."
  • QUOTE:
    • Official Title: A Pharmacokinetic Study of Brivanib (BMS-582664) in Subjects With Advanced Solid Tumor Malignancies and Normal Hepatic Function or Hepatocellular Carcinoma With Impaired Hepatic Function
    • Study Start Date : July 2007
    • Actual Primary Completion Date : June 2010
    • Actual Study Completion Date : June 2010
    • Arms and Interventions
      • Arm: Experimental: 1
      • Intervention/treatment
        • Drug: Brivanib
        • Tablet, Oral, Brivanib 400 mg, based on Day 1 PK, QD, until progression
        • Other Name: BMS-582664.
    • Outcome Measures
      • Primary Outcome Measures :
        1. The primary objective of this study is to determine the effect of BMS-582664 on subjects with varying levels of hepatic impairment and guide prescribers with regards to dosing in specialized populations [ Time Frame: throughout the study]
      • Secondary Outcome Measures :
        1. To assess safety and tolerability of BMS-582664 in subjects with HCC with mild, moderate, and severe hepatic impairment and in subjects with advanced malignancies with normal hepatic function [ Time Frame: by Day 1 and Day 28 Pharmacokinetics]
        2. To assess efficacy of BMS-582664 in subjects with advanced solid tumor malignancies and subjects with HCC by CT or MRI [ Time Frame: every 6 weeks until disease progression]

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