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NCT03345485 · FLOW

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Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21

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

groups
  1. description
    This is dose level 1 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 60mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG000
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min). Cohort 1
  2. description
    This is dose level 2 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 80mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG001
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min). Cohort 2
  3. description
    This is dose level 3 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 100mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle. In the 30-minute infusion study drug dosing had to be delayed in subsequent cycles due to thrombocytopenia, which was associated with an extremely high Cmax of Tinostamustine. To ensure that subjects continue the study treatment safely, the Sponsor decided to stop the investigation of the 30-minute infusion time and open cohorts with the 60-minute infusion in 3 subjects with relapse/refractory solid tumors.
    id
    FG002
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min). Cohort 3.
  4. description
    This is dose level 4 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 60mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG003
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min). Cohort 4
  5. description
    This is dose level 5 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG004
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min). Cohort 5
  6. description
    This is dose level 6 of the dose escalation phase (Phase 1) of the study. DLT of electrocardiogram QTc prolongation occurred 1 patient. Considering the DLT observed in this cohort and the rapid occurrence of treatment-induced thrombocytopenia (not meeting the DLT definitions), the SRC concluded as follows: * The dose of 100 mg/m2 was determined the MAD. * The dose level of 80 mg/m2 given i.v. over 60 minutes was determined to be the MTD * The dose level of 80 mg/m2 given i.v. over 60 minutes on Day 1 and Day 15 of each 4-week treatment cycle was determined to be the RP2D.
    id
    FG005
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min). Cohort 6
  7. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG006
    title
    Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort.
  8. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG007
    title
    Tinostamustine (EDO-S101) - Phase 2 STS Cohort.
  9. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG008
    title
    Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort.
  10. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG009
    title
    Tinostamustine (EDO-S101) - Phase 2 OC Cohort.
  11. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG010
    title
    Tinostamustine (EDO-S101) - Phase 2 EC Cohort.
  12. description
    Tinostamustine at dose of 60mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG011
    title
    Tinostamustine (EDO-S101) - Substudy 1
periods
  1. 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
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        3
      type
      Do not have a post-dose tumour assessment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        12
      11. group Id
        FG010
        num Subjects
        6
      12. group Id
        FG011
        num Subjects
        6
      comment
      Patients Treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        12
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        3
      comment
      Phase 1: Patients are reported as completed if they have completed cycle 1. Phase 2: Patients who have at least 1 post-baseline tumour response assessment is reported as completed.
      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
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Adults with histologically confirmed diagnosis of advanced or metastatic solid tumors, disease should have progressed during or following at least 1 previous line of therapy and no other standard therapy with proven clinical benefit is available or recommended based on the investigator's individual risk-benefit assessment for the patient.
recruitment Details
Subjects were recruited by physicians at the study sites between Nov-2017 and Aug-2022.
Complete source fields
groups
  1. description
    This is dose level 1 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 60mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG000
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min). Cohort 1
  2. description
    This is dose level 2 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 80mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG001
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min). Cohort 2
  3. description
    This is dose level 3 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 100mg/m2 administered i.v. over 30min on D1 and D15 of each 4-week cycle. In the 30-minute infusion study drug dosing had to be delayed in subsequent cycles due to thrombocytopenia, which was associated with an extremely high Cmax of Tinostamustine. To ensure that subjects continue the study treatment safely, the Sponsor decided to stop the investigation of the 30-minute infusion time and open cohorts with the 60-minute infusion in 3 subjects with relapse/refractory solid tumors.
    id
    FG002
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min). Cohort 3.
  4. description
    This is dose level 4 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 60mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG003
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min). Cohort 4
  5. description
    This is dose level 5 of the dose escalation phase (Phase 1) of the study. Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle. The decision to escalate to the next dose level occurred after all 3 subjects completed the Dose-limiting toxicity (DLT) observation time and were evaluated for safety and toxicity.
    id
    FG004
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min). Cohort 5
  6. description
    This is dose level 6 of the dose escalation phase (Phase 1) of the study. DLT of electrocardiogram QTc prolongation occurred 1 patient. Considering the DLT observed in this cohort and the rapid occurrence of treatment-induced thrombocytopenia (not meeting the DLT definitions), the SRC concluded as follows: * The dose of 100 mg/m2 was determined the MAD. * The dose level of 80 mg/m2 given i.v. over 60 minutes was determined to be the MTD * The dose level of 80 mg/m2 given i.v. over 60 minutes on Day 1 and Day 15 of each 4-week treatment cycle was determined to be the RP2D.
    id
    FG005
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min). Cohort 6
  7. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG006
    title
    Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort.
  8. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG007
    title
    Tinostamustine (EDO-S101) - Phase 2 STS Cohort.
  9. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG008
    title
    Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort.
  10. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG009
    title
    Tinostamustine (EDO-S101) - Phase 2 OC Cohort.
  11. description
    Tinostamustine at dose of 80mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG010
    title
    Tinostamustine (EDO-S101) - Phase 2 EC Cohort.
  12. description
    Tinostamustine at dose of 60mg/m2 administered i.v. over 60min on D1 and D15 of each 4-week cycle.
    id
    FG011
    title
    Tinostamustine (EDO-S101) - Substudy 1
periods
  1. 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
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        3
      type
      Do not have a post-dose tumour assessment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        12
      11. group Id
        FG010
        num Subjects
        6
      12. group Id
        FG011
        num Subjects
        6
      comment
      Patients Treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        12
      11. group Id
        FG010
        num Subjects
        4
      12. group Id
        FG011
        num Subjects
        3
      comment
      Phase 1: Patients are reported as completed if they have completed cycle 1. Phase 2: Patients who have at least 1 post-baseline tumour response assessment is reported as completed.
      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
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Adults with histologically confirmed diagnosis of advanced or metastatic solid tumors, disease should have progressed during or following at least 1 previous line of therapy and no other standard therapy with proven clinical benefit is available or recommended based on the investigator's individual risk-benefit assessment for the patient.
recruitment Details
Subjects were recruited by physicians at the study sites between Nov-2017 and Aug-2022.

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Preserved source evidence · Not medical advice