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NCT02464228 · FLOW

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Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy · Source last updated 2024-06-26

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

groups
  1. description
    Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally twice daily (BID) on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG000
    title
    Cohort AITL
  2. description
    Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG001
    title
    Cohort PTCL-NOS
  3. description
    Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG002
    title
    Cohort PTCL-NOS, CXCL12+
  4. description
    Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG003
    title
    Cohort Other
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Termination for Symptomatic Deterioration
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    3. 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
      Miscellaneous
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        2
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Only consented subjects who met all the eligibility criteria were enrolled in the study. All screening evaluations were to be completed within 4 weeks (28 days) of Cycle 1 Day 1. Screen failure reasons were not included in the database.
recruitment Details
The first subject was enrolled on 25 Feb 2016 (13 in Europe; 52 outside Europe) and the date of the last visit was 31 Mar 2021. Overall, 65 subjects were enrolled into cohorts with angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), PTCL-NOS whose tumors expressed high levels of C-X-C motif chemokine 12 (CXCL12+), and Other (anaplastic large cell lymphoma-anaplastic lymphoma kinase \[ALCL-ALK negative\] and PTCL-subtype not specified).
Complete source fields
groups
  1. description
    Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally twice daily (BID) on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG000
    title
    Cohort AITL
  2. description
    Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG001
    title
    Cohort PTCL-NOS
  3. description
    Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG002
    title
    Cohort PTCL-NOS, CXCL12+
  4. description
    Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
    id
    FG003
    title
    Cohort Other
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Termination for Symptomatic Deterioration
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Physician Decision
    3. 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
      Miscellaneous
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      type
      Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        2
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        11
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Only consented subjects who met all the eligibility criteria were enrolled in the study. All screening evaluations were to be completed within 4 weeks (28 days) of Cycle 1 Day 1. Screen failure reasons were not included in the database.
recruitment Details
The first subject was enrolled on 25 Feb 2016 (13 in Europe; 52 outside Europe) and the date of the last visit was 31 Mar 2021. Overall, 65 subjects were enrolled into cohorts with angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), PTCL-NOS whose tumors expressed high levels of C-X-C motif chemokine 12 (CXCL12+), and Other (anaplastic large cell lymphoma-anaplastic lymphoma kinase \[ALCL-ALK negative\] and PTCL-subtype not specified).

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Preserved source evidence · Not medical advice