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NCT01672736 · FLOW

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A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma · Source last updated 2018-09-13

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

groups
  1. description
    ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration
    id
    FG000
    title
    ASP7487, Velcade, Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Available drug expired on 31 May 16
    milestones
    1. achievements
      1. comment
        Phase I study part stopped early due to manufacturer's decision to stop further drug development.
        group Id
        FG000
        num Subjects
        19
      type
      STARTED
    2. achievements
      1. comment
        3 patients taken off study due to non-availability of further study (Linsitinib) drug supply.
        group Id
        FG000
        num Subjects
        16
      comment
      Phase II part of the study not done due to termination of further study drug development.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Subject enrollment under this IND was stopped prematurely due to the drug manufacturer's decision to terminate the development of the study drug, Linsitinib (letter dated 1 November 2015). Therefore, the study did not proceed to Phase II portion of the study protocol. The available study drug supply at the study sites expired on 31 May 2016.
Complete source fields
groups
  1. description
    ASP7487 administered orally 75, 100 and 150 mg) BID continuously for each cycle. Bortezomib administered at 1.3 mg/m2 twice weekly for the first 8 21 day cycles and once weekly beyond cycle 9 for 35 day cycles. Dexamethasone is administered on bortezomib administration days at 20 mg ASP7487, Velcade, Dexamethasone: ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration
    id
    FG000
    title
    ASP7487, Velcade, Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Available drug expired on 31 May 16
    milestones
    1. achievements
      1. comment
        Phase I study part stopped early due to manufacturer's decision to stop further drug development.
        group Id
        FG000
        num Subjects
        19
      type
      STARTED
    2. achievements
      1. comment
        3 patients taken off study due to non-availability of further study (Linsitinib) drug supply.
        group Id
        FG000
        num Subjects
        16
      comment
      Phase II part of the study not done due to termination of further study drug development.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Subject enrollment under this IND was stopped prematurely due to the drug manufacturer's decision to terminate the development of the study drug, Linsitinib (letter dated 1 November 2015). Therefore, the study did not proceed to Phase II portion of the study protocol. The available study drug supply at the study sites expired on 31 May 2016.

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Preserved source evidence · Not medical advice