TriangleNCT02103478 · OUTCOME
Mean Decitabine Area Under the Plasma Concentration Versus Time Curve Ratio (5-day AUC0-t) in Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_LEAST_SQUARES_MEAN
- Unit
- Ratio of Geometric LSM
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- Pre-dose to Day 5
What was measured
Decitabine 5-day AUC ratio following IV decitabine 20 mg/m\^2 infusion versus concomitant oral administration of decitabine + cedazuridine (E7727) or ASTX727 in the dose combination and fixed-dose combination stages, respectively. AUC0-t (the area under the concentration-time curve from time zero to the time of the last (tlast) quantifiable concentration (Ct)) by dose/cohort and course/days was used for estimating decitabine cumulative 5-day AUC0-t exposures.
Analysis population: Participants with evaluable PK measurements are included. Phase 2 crossover design was used to compare AUC ratio for oral and IV administration.
Groups in this outcome
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either Sequence A: Oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2; or Sequence B: IV decitabine (20 mg/m\^2) Dailyx5 in Course 1 followed by cedazuridine + decitabine capsules Dailyx5 in Course 2 (28 days per course). In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
| Group | Source count |
|---|---|
| Phase 2 Dose Confirmation | 40 |
| Phase 2 Fixed-Dose Combination | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Dose Confirmation | 93.52 | Not reported | 82.10 | 106.50 | Not reported |
| Phase 2 Fixed-Dose Combination | 97.59 | Not reported | 80.48 | 118.30 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.10
- upper Limit
- 106.50
- value
- 93.52
- group Id
- OG001
- lower Limit
- 80.48
- upper Limit
- 118.30
- value
- 97.59
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- Decitabine 5-day AUC ratio following IV decitabine 20 mg/m\^2 infusion versus concomitant oral administration of decitabine + cedazuridine (E7727) or ASTX727 in the dose combination and fixed-dose combination stages, respectively. AUC0-t (the area under the concentration-time curve from time zero to the time of the last (tlast) quantifiable concentration (Ct)) by dose/cohort and course/days was used for estimating decitabine cumulative 5-day AUC0-t exposures.
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Participants were randomized in a 1:1 ratio to receive either Sequence A: Oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2; or Sequence B: IV decitabine (20 mg/m\^2) Dailyx5 in Course 1 followed by cedazuridine + decitabine capsules Dailyx5 in Course 2 (28 days per course). In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
- id
- OG000
- title
- Phase 2 Dose Confirmation
- description
- Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
- id
- OG001
- title
- Phase 2 Fixed-Dose Combination
- param Type
- GEOMETRIC_LEAST_SQUARES_MEAN
- population Description
- Participants with evaluable PK measurements are included. Phase 2 crossover design was used to compare AUC ratio for oral and IV administration.
- reporting Status
- POSTED
- time Frame
- Pre-dose to Day 5
- title
- Mean Decitabine Area Under the Plasma Concentration Versus Time Curve Ratio (5-day AUC0-t) in Phase 2
- type
- PRIMARY
- unit Of Measure
- Ratio of Geometric LSM
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Preserved source evidence · Not medical advice