TriangleNCT04362007 · OUTCOME
Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 28 days (Day1 to Day29)
What was measured
Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity. 1. Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion 2. Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment 3. Liver-associated abnormalities 4. Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours
Analysis population: The DLT analysis population include all subjects who received at least 1 dose of IMP and have available data necessary for DLT assessment during the DLT assessment period.
Groups in this outcome
Cohort 1
ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
Cohort 2
ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
| Group | Source count |
|---|---|
| Cohort 1 | 6 |
| Cohort 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity. 1. Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion 2. Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment 3. Liver-associated abnormalities 4. Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours
- groups
- description
- ASTX660 120mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
- id
- OG000
- title
- Cohort 1
- description
- ASTX660 150mg was orally administered once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21).
- id
- OG001
- title
- Cohort 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The DLT analysis population include all subjects who received at least 1 dose of IMP and have available data necessary for DLT assessment during the DLT assessment period.
- reporting Status
- POSTED
- time Frame
- 28 days (Day1 to Day29)
- title
- Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice