TriangleNCT02103478 · OUTCOME
Mean Maximum %LINE Demethylation in Phase 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-dose to Day 28 in Course 2 (28 days per course)
What was measured
Mean maximum % long interspread nuclear element-1 (LINE-1) demethylation decrease from baseline after oral decitabine + cedazuridine (E7727) or ASTX727 compared with IV decitabine 20 mg/m\^2 in the dose escalation stage.
Analysis population: The pharmacodynamic population includes all participants in Phase 1 with evaluable data who received at least one dose of investigational product.
Groups in this outcome
Phase 1 Dose Escalation Cohort 1
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
Phase 1 Dose Escalation Cohort 2
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort 1 | 6 |
| Phase 1 Dose Escalation Cohort 2 | 6 |
| Phase 1 Dose Escalation Cohort 3 | 6 |
| Phase 1 Dose Escalation Cohort 4 | 6 |
| Phase 1 Dose Escalation Cohort 5 | 18 |
Reported measurements
Course 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | -8.3 | 5.28 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | -9.2 | 5.84 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | -10.5 | 7.55 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | -12.1 | 7.82 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | -11.7 | 5.67 | Not reported | Not reported | Not reported |
Course 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | -8.0 | 3.56 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | -7.1 | 2.92 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | -8.9 | 5.42 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | -8.6 | 3.24 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | -7.5 | 5.47 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.28
- value
- -8.3
- group Id
- OG001
- spread
- 5.84
- value
- -9.2
- group Id
- OG002
- spread
- 7.55
- value
- -10.5
- group Id
- OG003
- spread
- 7.82
- value
- -12.1
- group Id
- OG004
- spread
- 5.67
- value
- -11.7
- title
- Course 1
- categories
- measurements
- group Id
- OG000
- spread
- 3.56
- value
- -8.0
- group Id
- OG001
- spread
- 2.92
- value
- -7.1
- group Id
- OG002
- spread
- 5.42
- value
- -8.9
- group Id
- OG003
- spread
- 3.24
- value
- -8.6
- group Id
- OG004
- spread
- 5.47
- value
- -7.5
- title
- Course 2
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 18
- units
- Participants
- description
- Mean maximum % long interspread nuclear element-1 (LINE-1) demethylation decrease from baseline after oral decitabine + cedazuridine (E7727) or ASTX727 compared with IV decitabine 20 mg/m\^2 in the dose escalation stage.
- dispersion Type
- Standard Deviation
- groups
- description
- Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
- id
- OG000
- title
- Phase 1 Dose Escalation Cohort 1
- description
- Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
- id
- OG001
- title
- Phase 1 Dose Escalation Cohort 2
- description
- Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
- id
- OG002
- title
- Phase 1 Dose Escalation Cohort 3
- description
- Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
- id
- OG003
- title
- Phase 1 Dose Escalation Cohort 4
- description
- Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
- id
- OG004
- title
- Phase 1 Dose Escalation Cohort 5
- param Type
- MEAN
- population Description
- The pharmacodynamic population includes all participants in Phase 1 with evaluable data who received at least one dose of investigational product.
- reporting Status
- POSTED
- time Frame
- Pre-dose to Day 28 in Course 2 (28 days per course)
- title
- Mean Maximum %LINE Demethylation in Phase 1
- type
- SECONDARY
- unit Of Measure
- Percent change
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Preserved source evidence · Not medical advice