Participant flow

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.

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. 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

   FG000

   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. 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

   FG001

   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. 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

   FG002

   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. 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

   FG003

   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. 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

   FG004

   title

   Phase 1 Cohort 5: 400mg/m2

6. description

   FF-10501-01 tablets BID every 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. 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

   FG005

   title

   Phase 1 Cohort 6: 500mg/m2

7. description

   FF-10501-01 tablets BID for 21 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle. 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

   FG006

   title

   Phase 1 Cohort 7: 400mg/m2 in MDS/CMML

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. 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

   FG007

   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: FF-10501-01 will be administered orally on Days 1-21 of a 28-day cycle. 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

   FG008

   title

   Phase 2a Cohort 9: 400mg/m2

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         5

      8. group Id

         FG007

         num Subjects

         7

      9. group Id

         FG008

         num Subjects

         17

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         5

      8. group Id

         FG007

         num Subjects

         7

      9. group Id

         FG008

         num Subjects

         17

      type

      Treated

   3. achievements

      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

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         6

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         7

      9. group Id

         FG008

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

For Phase 1, anticipated enrollment was 48 subjects; 38 subjects were enrolled and treated with FF-10501-01. For Phase 2, anticipated enrollment was 20 subjects; 17 were enrolled and treated with FF-10501-01.

recruitment Details

Participants were recruited based on physician referral at 2 academic medical centers between July 2014 and December 2018. The first participant was enrolled on August 21, 2014 and the last participant was enrolled on December 3, 2018. Study completion date was August 9, 2019.

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Preserved source evidence · Not medical advice