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NCT00105443 · FLOW

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A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2014-10-31

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

groups
  1. description
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
    id
    FG000
    title
    A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase
  2. description
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
    id
    FG001
    title
    A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase
  3. description
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section.
    id
    FG002
    title
    B1) Placebo - no Open Label Phase
  4. description
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section.
    id
    FG003
    title
    B2) Placebo First - Then Open Label Sorafenib Treatment Phase
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Radiological and symptomatic progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        256
      4. group Id
        FG003
        num Subjects
        47
      type
      STARTED
    2. achievements
      1. comment
        Subjects at Risk/Safety Population - partly in RG1 and RG3 (RG = Reporting Group for Safety Data)
        group Id
        FG000
        num Subjects
        240
      2. comment
        Subjects at Risk/Safety Population - partly in RG1 and RG3
        group Id
        FG001
        num Subjects
        57
      3. comment
        Subjects at Risk/Safety Population - partly in RG2 and RG4
        group Id
        FG002
        num Subjects
        255
      4. comment
        Subjects at Risk/Safety Population - partly in RG2 and RG4 as well as RG5
        group Id
        FG003
        num Subjects
        47
      type
      Received Treatment
    3. achievements
      1. comment
        228 participants directly switched to the Follow-up (FU) phase only
        group Id
        FG000
        num Subjects
        228
      2. comment
        47 participants continued with Sorafenib Open Label (OL); 10 first to FU prior to also switch to OL
        group Id
        FG001
        num Subjects
        57
      3. comment
        245 participants directly switched to the Follow-up (FU) phase
        group Id
        FG002
        num Subjects
        245
      4. comment
        36 participants switched to Sorafenib Open Label (OL); 11 first to FU prior to also switch to OL
        group Id
        FG003
        num Subjects
        47
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-Blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        180
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        219
      4. group Id
        FG003
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        4
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        16
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Progression by clinical judgment
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Progression, measurement proven
    9. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Disease progression, recurrence, relapse
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      Endpoint record not completed
    11. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Planned switch to OL; record incomplete
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Non-compliant with study medication
    milestones
    1. achievements
      1. comment
        At start of period, 228 participants directly switched to Follow-up (FU)
        group Id
        FG000
        num Subjects
        228
      2. comment
        At start of period, 47 participants directly switched to Open Label (OL) Sorafenib treatment
        group Id
        FG001
        num Subjects
        57
      3. comment
        At start of period, 245 participants directly switched to Follow-up (FU)
        group Id
        FG002
        num Subjects
        245
      4. comment
        At start of period, 36 participants directly switched to Open Label (OL) Sorafenib treatment
        group Id
        FG003
        num Subjects
        47
      type
      STARTED
    2. achievements
      1. comment
        In parallel to "Open Label treatment only" phase
        group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        In parallel to "Open Label treatment only" phase
        group Id
        FG002
        num Subjects
        245
      4. group Id
        FG003
        num Subjects
        0
      type
      Follow-up Only (no Open Label Treatment)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        In parallel to "Follow-up only" phase; participants received Sorafenib 400 mg bid
        group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        In parallel to "Follow-up only" phase; participants received Sorafenib 400 mg bid
        group Id
        FG003
        num Subjects
        36
      type
      Open Label Treatment Only (no Follow-up)
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        11
      type
      Follow-up First, Then Open Label
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        57 participants in total (47 + 10) received Open Label Sorafenib treatment (Subjects at Risk)
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        47 participants in total (36 + 11) received Open Label Sorafenib treatment (Subjects at Risk)
        group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        245
      4. group Id
        FG003
        num Subjects
        47
      type
      NOT COMPLETED
    title
    Follow-up and/or Open Label Nexavar
pre Assignment Details
After a 28 day screening period (902 subjects), 602 were randomized to Sorafenib (400 mg) twice daily (bid), or matching placebo. Majority of screen failures did not meet inclusion criteria. Efficacy population (intent-to-treat, ITT) was all randomized subjects (602), safety population was all subjects receiving at least 1 dose of study drug (599).
recruitment Details
Subjects with advanced hepatocellular carcinoma (HCC) were enrolled from Mar 10, 2005 to Apr 11, 2006 at 121 study centers in 21 countries around the Globe.
Complete source fields
groups
  1. description
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
    id
    FG000
    title
    A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase
  2. description
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
    id
    FG001
    title
    A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase
  3. description
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section.
    id
    FG002
    title
    B1) Placebo - no Open Label Phase
  4. description
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section.
    id
    FG003
    title
    B2) Placebo First - Then Open Label Sorafenib Treatment Phase
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Radiological and symptomatic progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        256
      4. group Id
        FG003
        num Subjects
        47
      type
      STARTED
    2. achievements
      1. comment
        Subjects at Risk/Safety Population - partly in RG1 and RG3 (RG = Reporting Group for Safety Data)
        group Id
        FG000
        num Subjects
        240
      2. comment
        Subjects at Risk/Safety Population - partly in RG1 and RG3
        group Id
        FG001
        num Subjects
        57
      3. comment
        Subjects at Risk/Safety Population - partly in RG2 and RG4
        group Id
        FG002
        num Subjects
        255
      4. comment
        Subjects at Risk/Safety Population - partly in RG2 and RG4 as well as RG5
        group Id
        FG003
        num Subjects
        47
      type
      Received Treatment
    3. achievements
      1. comment
        228 participants directly switched to the Follow-up (FU) phase only
        group Id
        FG000
        num Subjects
        228
      2. comment
        47 participants continued with Sorafenib Open Label (OL); 10 first to FU prior to also switch to OL
        group Id
        FG001
        num Subjects
        57
      3. comment
        245 participants directly switched to the Follow-up (FU) phase
        group Id
        FG002
        num Subjects
        245
      4. comment
        36 participants switched to Sorafenib Open Label (OL); 11 first to FU prior to also switch to OL
        group Id
        FG003
        num Subjects
        47
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-Blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        180
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        219
      4. group Id
        FG003
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        4
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        16
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Progression by clinical judgment
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      Progression, measurement proven
    9. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Disease progression, recurrence, relapse
    10. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      Endpoint record not completed
    11. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Planned switch to OL; record incomplete
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Non-compliant with study medication
    milestones
    1. achievements
      1. comment
        At start of period, 228 participants directly switched to Follow-up (FU)
        group Id
        FG000
        num Subjects
        228
      2. comment
        At start of period, 47 participants directly switched to Open Label (OL) Sorafenib treatment
        group Id
        FG001
        num Subjects
        57
      3. comment
        At start of period, 245 participants directly switched to Follow-up (FU)
        group Id
        FG002
        num Subjects
        245
      4. comment
        At start of period, 36 participants directly switched to Open Label (OL) Sorafenib treatment
        group Id
        FG003
        num Subjects
        47
      type
      STARTED
    2. achievements
      1. comment
        In parallel to "Open Label treatment only" phase
        group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        In parallel to "Open Label treatment only" phase
        group Id
        FG002
        num Subjects
        245
      4. group Id
        FG003
        num Subjects
        0
      type
      Follow-up Only (no Open Label Treatment)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        In parallel to "Follow-up only" phase; participants received Sorafenib 400 mg bid
        group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        In parallel to "Follow-up only" phase; participants received Sorafenib 400 mg bid
        group Id
        FG003
        num Subjects
        36
      type
      Open Label Treatment Only (no Follow-up)
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        11
      type
      Follow-up First, Then Open Label
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        57 participants in total (47 + 10) received Open Label Sorafenib treatment (Subjects at Risk)
        group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        47 participants in total (36 + 11) received Open Label Sorafenib treatment (Subjects at Risk)
        group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        228
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        245
      4. group Id
        FG003
        num Subjects
        47
      type
      NOT COMPLETED
    title
    Follow-up and/or Open Label Nexavar
pre Assignment Details
After a 28 day screening period (902 subjects), 602 were randomized to Sorafenib (400 mg) twice daily (bid), or matching placebo. Majority of screen failures did not meet inclusion criteria. Efficacy population (intent-to-treat, ITT) was all randomized subjects (602), safety population was all subjects receiving at least 1 dose of study drug (599).
recruitment Details
Subjects with advanced hepatocellular carcinoma (HCC) were enrolled from Mar 10, 2005 to Apr 11, 2006 at 121 study centers in 21 countries around the Globe.

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