NCT01121588 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- FG000
- title
- ALCL Arm
- description
- In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- FG001
- title
- IMT Arm
- description
- In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- FG002
- title
- Other Tumors
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 13
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Study Terminated by Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 2
- type
- Participant Refused Further Followup
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 2
- type
- Non-Specified Reasons
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 17
- group Id
- FG001
- num Subjects
- 9
- group Id
- FG002
- num Subjects
- 18
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 17
- group Id
- FG001
- num Subjects
- 9
- group Id
- FG002
- num Subjects
- 18
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- A total of 44 Anaplastic lymphoma kinase (ALK) genetic event positive participants were enrolled into the study and treated: 17 with anaplastic large cell lymphoma (ALCL), 9 with inflammatory myofibroblastic tumors (IMT), and 18 with other tumors (ALK-positive malignancies excluding non-small cell lung cancer).
Complete source fields
- groups
- description
- In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- FG000
- title
- ALCL Arm
- description
- In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- FG001
- title
- IMT Arm
- description
- In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- FG002
- title
- Other Tumors
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 13
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Study Terminated by Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 2
- type
- Participant Refused Further Followup
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 2
- type
- Non-Specified Reasons
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 17
- group Id
- FG001
- num Subjects
- 9
- group Id
- FG002
- num Subjects
- 18
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 17
- group Id
- FG001
- num Subjects
- 9
- group Id
- FG002
- num Subjects
- 18
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- A total of 44 Anaplastic lymphoma kinase (ALK) genetic event positive participants were enrolled into the study and treated: 17 with anaplastic large cell lymphoma (ALCL), 9 with inflammatory myofibroblastic tumors (IMT), and 18 with other tumors (ALK-positive malignancies excluding non-small cell lung cancer).
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