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NCT02193958 · OUTCOME

Determination of Objective Response (OR) Rates.

Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies · Source last updated 2025-03-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length.

What was measured

The OR endpoint: proportion of subjects w/ OR as best response (CR, CRi or PR) assessed at the end of Cycles 1 and 3. AML: CR - free of all symptoms related to leukemia, absolute neutrophil count \> 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, normal bone marrow with \< 5% blasts no Auer rods; CRi - CR with residual thrombocytopenia (platelet count \< 100 x 10\^9/L) or residual neutropenia (absolute neutrophil count \< 1.0 x 10\^9/L); PR - A ≥ 50% decrease in bone marrow blasts to 5 to 25% abnormal. MDS or CMML: CR - free of all symptoms related to leukemia, absolute neutrophil count ≥ 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, bone marrow ≤ 5% myeloblasts, w/ normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood; PR - All CR criteria with ≥50% decrease in bone marrow blasts over pre-treatment (but still \> 5%); Marrow CR - In bone marrow, ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment.

Groups in this outcome

Phase 1 Cohort 1: 50mg/m2

FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 1 Cohort 2: 100mg/m2

FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 1 Cohort 3: 200mg/m2

FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 1 Cohort 4: 300mg/m2

FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 1 Cohort 5: 400mg/m2

FF-10501-01 tablets BID for 14 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 1 Cohort 6: 500mg/m2

FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 1 Cohort 7: 400mg/m2

FF-10501-01 tablets BID every 21 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 1 Cohort 8: 400mg/m2

FF-10501-01 tablets BID for 28 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Phase 2a Cohort 9: 400mg/m2

FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1 Cohort 1: 50mg/m23
Phase 1 Cohort 2: 100mg/m23
Phase 1 Cohort 3: 200mg/m24
Phase 1 Cohort 4: 300mg/m24
Phase 1 Cohort 5: 400mg/m27
Phase 1 Cohort 6: 500mg/m25
Phase 1 Cohort 7: 400mg/m25
Phase 1 Cohort 8: 400mg/m27
Phase 2a Cohort 9: 400mg/m217

Reported measurements

Partial Response subjects
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Cohort 1: 50mg/m21Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 2: 100mg/m21Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 3: 200mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 4: 300mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 5: 400mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 6: 500mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 7: 400mg/m21Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 8: 400mg/m20Not reportedNot reportedNot reportedNot reported
Phase 2a Cohort 9: 400mg/m20Not reportedNot reportedNot reportedNot reported
Complete bone marrow remission (mCR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Cohort 1: 50mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 2: 100mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 3: 200mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 4: 300mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 5: 400mg/m21Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 6: 500mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 7: 400mg/m20Not reportedNot reportedNot reportedNot reported
Phase 1 Cohort 8: 400mg/m20Not reportedNot reportedNot reportedNot reported
Phase 2a Cohort 9: 400mg/m20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Partial Response subjects
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Complete bone marrow remission (mCR)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      17
    units
    Participants
description
The OR endpoint: proportion of subjects w/ OR as best response (CR, CRi or PR) assessed at the end of Cycles 1 and 3. AML: CR - free of all symptoms related to leukemia, absolute neutrophil count \> 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, normal bone marrow with \< 5% blasts no Auer rods; CRi - CR with residual thrombocytopenia (platelet count \< 100 x 10\^9/L) or residual neutropenia (absolute neutrophil count \< 1.0 x 10\^9/L); PR - A ≥ 50% decrease in bone marrow blasts to 5 to 25% abnormal. MDS or CMML: CR - free of all symptoms related to leukemia, absolute neutrophil count ≥ 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, bone marrow ≤ 5% myeloblasts, w/ normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood; PR - All CR criteria with ≥50% decrease in bone marrow blasts over pre-treatment (but still \> 5%); Marrow CR - In bone marrow, ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment.
groups
  1. description
    FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG000
    title
    Phase 1 Cohort 1: 50mg/m2
  2. description
    FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG001
    title
    Phase 1 Cohort 2: 100mg/m2
  3. description
    FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG002
    title
    Phase 1 Cohort 3: 200mg/m2
  4. description
    FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG003
    title
    Phase 1 Cohort 4: 300mg/m2
  5. description
    FF-10501-01 tablets BID for 14 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG004
    title
    Phase 1 Cohort 5: 400mg/m2
  6. description
    FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG005
    title
    Phase 1 Cohort 6: 500mg/m2
  7. description
    FF-10501-01 tablets BID every 21 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG006
    title
    Phase 1 Cohort 7: 400mg/m2
  8. description
    FF-10501-01 tablets BID for 28 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG007
    title
    Phase 1 Cohort 8: 400mg/m2
  9. description
    FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    id
    OG008
    title
    Phase 2a Cohort 9: 400mg/m2
param Type
NUMBER
reporting Status
POSTED
time Frame
OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length.
title
Determination of Objective Response (OR) Rates.
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice