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NCT01245062 · FLOW

Participant flow

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma · Source last updated 2018-04-05

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

groups
  1. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
    id
    FG000
    title
    Trametinib
  2. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
    id
    FG001
    title
    Chemotherapy
  3. description
    Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
    id
    FG002
    title
    Cross-over From Chemotherapy to Trametinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrew Consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      type
      Study closed/ terminated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        214
      2. group Id
        FG001
        num Subjects
        108
      3. group Id
        FG002
        num Subjects
        0
      comment
      Par. randomized onto study.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        173
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        0
      comment
      Par. completed the study as they died during the conduct of the study.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomization and Crossover Phase
  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
        1
      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
        1
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrew Consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      Study closed/ terminated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        As of the data cut on December 16, 2016, 70 of 108 participants crossed over from CT to trametinib.
        group Id
        FG002
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        53
      comment
      Par. completed the study as they died during the conduct of the study.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Cross-over Phase
pre Assignment Details
Participants (par.) were stratified for lactate dehydrogenase and prior CT for advanced or metastatic disease. 1059 par. were screened and 322 were enrolled to receive trametinib (214 par.) or CT (108 par.) until disease progression, death, or withdrawal. Par. randomized to CT were allowed to cross-over to trametinib if disease progressed.
recruitment Details
This was a randomized open-label, multi-center Phase III study to evaluate the efficacy and safety of single agent trametinib compared with chemotherapy (CT) (dacarbazine or paclitaxel). Participants (par.) were enrolled by 86 sites in 19 countries from December 2010 to July 2011. Results as of 16 December 2016 data-cut have been presented.
Complete source fields
groups
  1. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
    id
    FG000
    title
    Trametinib
  2. description
    Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
    id
    FG001
    title
    Chemotherapy
  3. description
    Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.
    id
    FG002
    title
    Cross-over From Chemotherapy to Trametinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrew Consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      type
      Study closed/ terminated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        214
      2. group Id
        FG001
        num Subjects
        108
      3. group Id
        FG002
        num Subjects
        0
      comment
      Par. randomized onto study.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        173
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        0
      comment
      Par. completed the study as they died during the conduct of the study.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Randomization and Crossover Phase
  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
        1
      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
        1
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        4
      type
      Withdrew Consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        11
      type
      Study closed/ terminated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        As of the data cut on December 16, 2016, 70 of 108 participants crossed over from CT to trametinib.
        group Id
        FG002
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        53
      comment
      Par. completed the study as they died during the conduct of the study.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Cross-over Phase
pre Assignment Details
Participants (par.) were stratified for lactate dehydrogenase and prior CT for advanced or metastatic disease. 1059 par. were screened and 322 were enrolled to receive trametinib (214 par.) or CT (108 par.) until disease progression, death, or withdrawal. Par. randomized to CT were allowed to cross-over to trametinib if disease progressed.
recruitment Details
This was a randomized open-label, multi-center Phase III study to evaluate the efficacy and safety of single agent trametinib compared with chemotherapy (CT) (dacarbazine or paclitaxel). Participants (par.) were enrolled by 86 sites in 19 countries from December 2010 to July 2011. Results as of 16 December 2016 data-cut have been presented.

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Preserved source evidence · Not medical advice