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A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.
Subjects will receive FF-10501-01 orally on a twice daily schedule for 14, 21 or 28 days repeated every 28 days (=1 cycle). Disease assessments, including analysis of blood and bone marrow aspirates, will be performed at the end of Cycle 1 and every 2 cycles thereafter. Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10501-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in condition that prevent further study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | Experimental | FF-10501-01 tablets BID every 14 days of a 28-day cycle. |
|
| Phase 1 Cohort 2: 100mg/m2 | Experimental | FF-10501-01 tablets BID every 14 days of a 28-day cycle. |
|
| Phase 1 Cohort 3: 200mg/m2 | Experimental | FF-10501-01 tablets BID every 14 days of a 28-day cycle. |
|
| Phase 1 Cohort 4: 300mg/m2 | Experimental | FF-10501-01 tablets BID every 14 days of a 28-day cycle. |
|
| Phase 1 Cohort 5: 400mg/m2 | Experimental | FF-10501-01 tablets BID every 14 days of a 28-day cycle. |
|
| Phase 1 Cohort 6: 500mg/m2 | Experimental | FF-10501-01 tablets BID every 14 days of a 28-day cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FF-10501-01 | Drug | FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6), Days 1-21 of a 28-say cycle (Cohort 7), Days 1-28 of a 28-day cycle (Cohort 8) or Days 1-21 of a 28-say cycle (Cohort 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessed by Adverse Events | Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Objective Response (OR) Rates. | 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. |
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Inclusion Criteria:
Phase 1:
Phase 2a:
MDS/CMML, relapsed from, or refractory to, prior HMA therapy; the latter defined as failure to achieve clinical remission (CR), partial remission (PR) or hematologic improvement (HI) after previous HMA therapy (≥ 4 cycles of azacitidine or decitabine), or progression during, or toxicity to previous HMA therapy precluding further HMA treatment, and,
Bone marrow blast count ≥ 10% or peripheral blast count ≥ 5%, or IPSS-R score ≥ 3.5.
creatinine ≤ 2.0 mg/dL, or calculated creatinine clearance ≥ 45 mL/min
total bilirubin ≤ 2 times the upper limit of normal (ULN)
ALT/AST ≤ 2 times ULN
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Garcia-Manero, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic at Taussig Cancer Center | Cleveland | Ohio | 44195 | United States | ||
| M D Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32264726 | Derived | Garcia-Manero G, Pemmaraju N, Alvarado Y, Naqvi K, Ravandi F, Jabbour E, De Lumpa R, Kantarjian H, Advani A, Mukherjee S, Gerds A, Carraway HE, Nazha A, Iwamura H, Murase M, Bavisotto L, Kurman M, Maier G, Johansen M, Sekeres MA. Results of a Phase 1/2a dose-escalation study of FF-10501-01, an IMPDH inhibitor, in patients with acute myeloid leukemia or myelodysplastic syndromes. Leuk Lymphoma. 2020 Aug;61(8):1943-1953. doi: 10.1080/10428194.2020.1747065. Epub 2020 Apr 7. |
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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.
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| FG003 | 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. 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. |
| FG004 | 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. 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. |
| FG005 | Phase 1 Cohort 6: 500mg/m2 | 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. |
| FG006 | Phase 1 Cohort 7: 400mg/m2 in MDS/CMML | 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. |
| FG007 | 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. 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. |
| FG008 | Phase 2a Cohort 9: 400mg/m2 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Assessed by Adverse Events | Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity | Posted | Number | participants | 12 months |
|
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.
Definitions do not differ from clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Clinical Operations | FUJIFILM Pharmaceuticals U.S.A, Inc. | (617) 945-3763 | fphucontact@fujifilm.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2017 | Feb 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2018 | Feb 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Phase 2a Cohort 7: 400mg/m2 in MDS/CMML | Experimental | FF-10501-01 tablets BID every 21 days of a 28-day cycle. |
|
| Phase 1 Cohort 8: 400mg/m2 | Experimental | FF-10501-01 tablets BID every 28 days of a 28 day cycle. |
|
| Phase 2a Cohort 9: 400mg/m2 | Experimental | FF-10501-01 tablets BID every 21 days of a 28-day cycle. |
|
|
|
| OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length. |
| Houston |
| Texas |
| 77030 |
| United States |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
|
|
| Secondary | Determination of Objective Response (OR) Rates. | 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. | Posted | Number | participants | OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length. |
|
|
|
| 3 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | 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 | 2 | 3 | 3 | 3 |
| EG002 | 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. | 3 | 4 | 4 | 4 | 4 | 4 |
| EG003 | 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. | 4 | 4 | 3 | 4 | 4 | 4 |
| EG004 | 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 |
| EG005 | 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. | 4 | 5 | 5 | 5 | 5 | 5 |
| EG006 | 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. | 2 | 5 | 4 | 5 | 5 | 5 |
| EG007 | 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. | 5 | 7 | 7 | 7 | 7 | 7 |
| EG008 | 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. | 8 | 17 | 15 | 17 | 17 | 17 |
| cellulitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| septic shock | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| hemorrhage intracranial | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| histiocytosis hematophagic | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| pyrexia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| non-cardiac chest pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hematoma | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| mucosal inflammation | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| enterocolitis infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| sepsis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| pericardial effusion | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| pericarditis | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| melena | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| tooth infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| enterobacter bacteremia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| ecthyma | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| periorbital cellulitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| stenotrophomonas infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| escherichia bacteremia/sepsis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hematuria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| enterococcla infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| clostridium difficile colitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| colitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| stomatitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| fatigue | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| non-cardiac chest pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| edema peripheral | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| pyrexia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| gait disturbance | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| mucosal inflammation | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Non-systematic Assessment |
|
| alanine aminotransferase increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
|
| blood bilirubin increased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
|
| platelet count decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
|
| decreased appetitie | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hypomagnesemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hypophosphatemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| confusional state | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| delirium | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| hypotension | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Complete bone marrow remission (mCR) |
|