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NCT00101413 · FLOW

Participant flow

BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC) · Source last updated 2013-10-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    id
    FG000
    title
    Sorafenib
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. comment
        Safety data collected for 4 subjects after 30 Jun 2005 until 11 Apr 2008.
        group Id
        FG000
        num Subjects
        52
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
52 of 54 enrolled patients started treatment. The analysis population consisted of 52 subjects for the intent to treat (ITT) and safety analyses and 51 subjects in the evaluable subject analysis (1 had lung metastases from pancreatic cancer).
recruitment Details
Study conducted in Germany and USA (1 center each) from Apr 2004 to Jun 2005. Recruitment in 2 phases: Interim analysis (IA) to be performed after treatment of 29 patients; final analysis planned after additional 21 patients. Final analysis data cut-off date 30 Jun 2005; safety data collected for the 4 ongoing subjects until 11 Apr 2008.
Complete source fields
groups
  1. description
    Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
    id
    FG000
    title
    Sorafenib
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. comment
        Safety data collected for 4 subjects after 30 Jun 2005 until 11 Apr 2008.
        group Id
        FG000
        num Subjects
        52
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
52 of 54 enrolled patients started treatment. The analysis population consisted of 52 subjects for the intent to treat (ITT) and safety analyses and 51 subjects in the evaluable subject analysis (1 had lung metastases from pancreatic cancer).
recruitment Details
Study conducted in Germany and USA (1 center each) from Apr 2004 to Jun 2005. Recruitment in 2 phases: Interim analysis (IA) to be performed after treatment of 29 patients; final analysis planned after additional 21 patients. Final analysis data cut-off date 30 Jun 2005; safety data collected for the 4 ongoing subjects until 11 Apr 2008.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice