NCT02193958 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Other-event reporting threshold: 5%

Definitions do not differ from clinicaltrials.gov

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	2 / 3	3 / 3	3 / 3
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.	2 / 3	3 / 3	2 / 3
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.	4 / 4	4 / 4	3 / 4
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.	3 / 4	4 / 4	4 / 4
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.	7 / 7	7 / 7	7 / 7
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.	5 / 5	5 / 5	4 / 5
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.	4 / 5	5 / 5	2 / 5
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.	7 / 7	7 / 7	5 / 7
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.	15 / 17	17 / 17	8 / 17

Group identifiers: EG000: Phase 1 Cohort 1: 50mg/m2 · EG001: Phase 1 Cohort 2: 100mg/m2 · EG002: Phase 1 Cohort 3: 200mg/m2 · EG003: Phase 1 Cohort 4: 300mg/m2 · EG004: Phase 1 Cohort 5: 400mg/m2 · EG005: Phase 1 Cohort 6: 500mg/m2 · EG006: Phase 1 Cohort 7: 400mg/m2 · EG007: Phase 1 Cohort 8: 400mg/m2 · EG008: Phase 2a Cohort 9: 400mg/m2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
4
group Id
EG002
num Affected
2
num At Risk
4
num Events
3
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
4
num At Risk
7
num Events
5
group Id
EG005
num Affected
2
num At Risk
5
num Events
2
group Id
EG006
num Affected
1
num At Risk
5
num Events
1
group Id
EG007
num Affected
6
num At Risk
7
num Events
9
group Id
EG008
num Affected
3
num At Risk
17
num Events
3
term
pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
2
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
2
num At Risk
17
num Events
3
term
febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
hemorrhage intracranial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
2
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
histiocytosis hematophagic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
17
num Events
1
term
non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
hematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
mucosal inflammation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
3
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
2
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
3
num At Risk
17
term
abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
4
group Id
EG004
num Affected
4
num At Risk
7
group Id
EG005
num Affected
2
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
5
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
5
num At Risk
17
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
5
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
3
num At Risk
7
group Id
EG008
num Affected
7
num At Risk
17
term
nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
3
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
5
num At Risk
17
term
stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
3
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
3
num At Risk
17
term
fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
4
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
edema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
pyrexia

Complete source fields

description

Definitions do not differ from clinicaltrials.gov

event Groups

deaths Num Affected
3
deaths Num At Risk
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
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1 Cohort 1: 50mg/m2
deaths Num Affected
2
deaths Num At Risk
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
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase 1 Cohort 2: 100mg/m2
deaths Num Affected
3
deaths Num At Risk
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
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Phase 1 Cohort 3: 200mg/m2
deaths Num Affected
4
deaths Num At Risk
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
EG003
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Phase 1 Cohort 4: 300mg/m2
deaths Num Affected
7
deaths Num At Risk
7
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
EG004
other Num Affected
7
other Num At Risk
7
serious Num Affected
7
serious Num At Risk
7
title
Phase 1 Cohort 5: 400mg/m2
deaths Num Affected
4
deaths Num At Risk
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 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
EG005
other Num Affected
5
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Phase 1 Cohort 6: 500mg/m2
deaths Num Affected
2
deaths Num At Risk
5
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
EG006
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Phase 1 Cohort 7: 400mg/m2
deaths Num Affected
5
deaths Num At Risk
7
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
EG007
other Num Affected
7
other Num At Risk
7
serious Num Affected
7
serious Num At Risk
7
title
Phase 1 Cohort 8: 400mg/m2
deaths Num Affected
8
deaths Num At Risk
17
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
EG008
other Num Affected
17
other Num At Risk
17
serious Num Affected
15
serious Num At Risk
17
title
Phase 2a Cohort 9: 400mg/m2

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
3
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
2
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
3
num At Risk
17
term
abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
4
group Id
EG004
num Affected
4
num At Risk
7
group Id
EG005
num Affected
2
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
5
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
5
num At Risk
17
term
diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
3
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
5
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
3
num At Risk
7
group Id
EG008
num Affected
7
num At Risk
17
term
nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
3
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
7
group Id
EG008
num Affected
5
num At Risk
17
term
stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
3
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
3
num At Risk
17
term
fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
2
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
4
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
edema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
5
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
7
group Id
EG008
num Affected
0
num At Risk
17
term
pyrexia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
4
group Id
EG002
num Affected
2
num At Risk
4
num Events
3
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
4
num At Risk
7
num Events
5
group Id
EG005
num Affected
2
num At Risk
5
num Events
2
group Id
EG006
num Affected
1
num At Risk
5
num Events
1
group Id
EG007
num Affected
6
num At Risk
7
num Events
9
group Id
EG008
num Affected
3
num At Risk
17
num Events
3
term
pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
2
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
2
num At Risk
17
num Events
3
term
febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
1
num At Risk
7
num Events
1
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
hemorrhage intracranial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
2
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
histiocytosis hematophagic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
2
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
1
num At Risk
5
num Events
1
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
17
num Events
1
term
non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
hematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
7
num Events
0
group Id
EG005
num Affected
0
num At Risk
5
num Events
0
group Id
EG006
num Affected
0
num At Risk
5
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
17
num Events
0
term
mucosal inflammation

time Frame

Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice