TriangleNCT02103478 · OUTCOME
Time to Maximum Observed Plasma Concentration (Tmax) of Decitabine in Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- At specific timepoints from 0 to 24 hours post-dose
What was measured
Tmax is the time to reach maximum plasma concentration for decitabine. PK parameters for plasma decitabine are reported for the dose confirmation and fixed-dose combination stages.
Analysis population: Participants with evaluable PK measurements are included.
Groups in this outcome
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules 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 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 | 49 |
| Phase 2 Fixed-Dose Combination | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Dose Confirmation | 1.00 | Not reported | 0.47 | 3.00 | Not reported |
| Phase 2 Fixed-Dose Combination | 0.95 | Not reported | 0.47 | 2.12 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.47
- upper Limit
- 3.00
- value
- 1.00
- group Id
- OG001
- lower Limit
- 0.47
- upper Limit
- 2.12
- value
- 0.95
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 29
- units
- Participants
- description
- Tmax is the time to reach maximum plasma concentration for decitabine. PK parameters for plasma decitabine are reported for the dose confirmation and fixed-dose combination stages.
- dispersion Type
- Full Range
- groups
- description
- Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules 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 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
- MEDIAN
- population Description
- Participants with evaluable PK measurements are included.
- reporting Status
- POSTED
- time Frame
- At specific timepoints from 0 to 24 hours post-dose
- title
- Time to Maximum Observed Plasma Concentration (Tmax) of Decitabine in Phase 2
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice