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NCT00753415 · FLOW

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A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002) · Source last updated 2015-03-17

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

groups
  1. description
    Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
    id
    FG000
    title
    Part A: V935 LD
  2. description
    Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
    id
    FG001
    title
    Part A: V934 LD(3)+V935 LD
  3. description
    Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
    id
    FG002
    title
    Part A: V935 HD
  4. description
    Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    FG003
    title
    Part A: V934 HD(3)+V935 HD
  5. description
    Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    FG004
    title
    Part A: V934 HD(5)+V935 HD
  6. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
    id
    FG005
    title
    Part B: V935 LD/V934 Booster
  7. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG006
    title
    Part B: V934 LD(3)+V935 LD/V934 Booster
  8. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG007
    title
    Part B: V935 HD/V934 Booster
  9. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG008
    title
    Part B: V934 HD(3)+V935 HD/V934 Booster
  10. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG009
    title
    Part B: V934 HD(5)+V934 HD/V934 Booster
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
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Disease progression
    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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      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
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A
  2. drop Withdraws
    1. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    2. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      type
      Disease progression
    milestones
    1. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. comment
        Of 2 eligible participants who completed Part A, 1 chose to enter Part B
        group Id
        FG005
        num Subjects
        1
      7. comment
        Of 3 eligible participants who completed Part A, 2 chose to enter Part B
        group Id
        FG006
        num Subjects
        2
      8. comment
        Of 8 eligible participants who completed Part A, 7 chose to enter Part B
        group Id
        FG007
        num Subjects
        7
      9. comment
        9 participants who completed Part A were eligible and enrolled in Part B
        group Id
        FG008
        num Subjects
        9
      10. comment
        Of 10 eligible participants who completed Part A, 9 chose to enter Part B
        group Id
        FG009
        num Subjects
        9
      type
      STARTED
    2. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Part B
pre Assignment Details
Of the 37 participants who were enrolled in Part A, 32 participants completed and were eligible to enroll in the optional extension study Part B. There were 28 participants who elected to enroll in Part B.
recruitment Details
V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.
Complete source fields
groups
  1. description
    Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
    id
    FG000
    title
    Part A: V935 LD
  2. description
    Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
    id
    FG001
    title
    Part A: V934 LD(3)+V935 LD
  3. description
    Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
    id
    FG002
    title
    Part A: V935 HD
  4. description
    Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    FG003
    title
    Part A: V934 HD(3)+V935 HD
  5. description
    Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    FG004
    title
    Part A: V934 HD(5)+V935 HD
  6. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
    id
    FG005
    title
    Part B: V935 LD/V934 Booster
  7. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG006
    title
    Part B: V934 LD(3)+V935 LD/V934 Booster
  8. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG007
    title
    Part B: V935 HD/V934 Booster
  9. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG008
    title
    Part B: V934 HD(3)+V935 HD/V934 Booster
  10. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    FG009
    title
    Part B: V934 HD(5)+V934 HD/V934 Booster
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
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Disease progression
    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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      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
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part A
  2. drop Withdraws
    1. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    2. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        1
      type
      Disease progression
    milestones
    1. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. comment
        Of 2 eligible participants who completed Part A, 1 chose to enter Part B
        group Id
        FG005
        num Subjects
        1
      7. comment
        Of 3 eligible participants who completed Part A, 2 chose to enter Part B
        group Id
        FG006
        num Subjects
        2
      8. comment
        Of 8 eligible participants who completed Part A, 7 chose to enter Part B
        group Id
        FG007
        num Subjects
        7
      9. comment
        9 participants who completed Part A were eligible and enrolled in Part B
        group Id
        FG008
        num Subjects
        9
      10. comment
        Of 10 eligible participants who completed Part A, 9 chose to enter Part B
        group Id
        FG009
        num Subjects
        9
      type
      STARTED
    2. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Part B
pre Assignment Details
Of the 37 participants who were enrolled in Part A, 32 participants completed and were eligible to enroll in the optional extension study Part B. There were 28 participants who elected to enroll in Part B.
recruitment Details
V935 alone or in combination with V934 was administered to 37 participants with selected solid tumors in Part A.

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