TriangleNCT02103478 · OUTCOME
Area Under the Concentration Versus Time Curve of Cedazuridine (E7727) and Cedazuridine-epimer
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- At specified timepoints from 0 to 24 hours post-dose
What was measured
AUC is a measure of the plasma concentration of the drug over time (AUC0-8). PK parameters are reported for the dose escalation stage by cohort in Phase 1 and dose confirmation and fixed-dose combination stages in Phase 2.
Analysis population: Participants with evaluable PK measurements are included.
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).
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 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 | 19 |
| Phase 2 Dose Confirmation | 37 |
| Phase 2 Fixed-Dose Combination | 19 |
Reported measurements
Cedazuridine
| 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 | 19 |
| Phase 2 Dose Confirmation | 32 |
| Phase 2 Fixed-Dose Combination | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 1650 | 43 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 1990 | 64 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 3190 | 53 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 4830 | 51 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 3490 | 46 | Not reported | Not reported | Not reported |
| Phase 2 Dose Confirmation | 2370 | 56.8 | Not reported | Not reported | Not reported |
| Phase 2 Fixed-Dose Combination | 1510 | 49.4 | Not reported | Not reported | Not reported |
Cedazuridine-epimer
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort 1 | 6 |
| Phase 1 Dose Escalation Cohort 2 | 6 |
| Phase 1 Dose Escalation Cohort 3 | 5 |
| Phase 1 Dose Escalation Cohort 4 | 3 |
| Phase 1 Dose Escalation Cohort 5 | 12 |
| Phase 2 Dose Confirmation | 37 |
| Phase 2 Fixed-Dose Combination | 19 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 503 | 20 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 917 | 64 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 1670 | 48 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 2180 | 34 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 1560 | 56 | Not reported | Not reported | Not reported |
| Phase 2 Dose Confirmation | 1190 | 48.3 | Not reported | Not reported | Not reported |
| Phase 2 Fixed-Dose Combination | 710 | 38 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 43
- value
- 1650
- group Id
- OG001
- spread
- 64
- value
- 1990
- group Id
- OG002
- spread
- 53
- value
- 3190
- group Id
- OG003
- spread
- 51
- value
- 4830
- group Id
- OG004
- spread
- 46
- value
- 3490
- group Id
- OG005
- spread
- 56.8
- value
- 2370
- group Id
- OG006
- spread
- 49.4
- value
- 1510
- 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
- 19
- group Id
- OG005
- value
- 32
- group Id
- OG006
- value
- 14
- units
- Participants
- title
- Cedazuridine
- categories
- measurements
- group Id
- OG000
- spread
- 20
- value
- 503
- group Id
- OG001
- spread
- 64
- value
- 917
- group Id
- OG002
- spread
- 48
- value
- 1670
- group Id
- OG003
- spread
- 34
- value
- 2180
- group Id
- OG004
- spread
- 56
- value
- 1560
- group Id
- OG005
- spread
- 48.3
- value
- 1190
- group Id
- OG006
- spread
- 38
- value
- 710
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 37
- group Id
- OG006
- value
- 19
- units
- Participants
- title
- Cedazuridine-epimer
- 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
- 19
- group Id
- OG005
- value
- 37
- group Id
- OG006
- value
- 19
- units
- Participants
- description
- AUC is a measure of the plasma concentration of the drug over time (AUC0-8). PK parameters are reported for the dose escalation stage by cohort in Phase 1 and dose confirmation and fixed-dose combination stages in Phase 2.
- dispersion Type
- Geometric Coefficient of Variation
- 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
- 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
- OG005
- 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
- OG006
- title
- Phase 2 Fixed-Dose Combination
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants with evaluable PK measurements are included.
- reporting Status
- POSTED
- time Frame
- At specified timepoints from 0 to 24 hours post-dose
- title
- Area Under the Concentration Versus Time Curve of Cedazuridine (E7727) and Cedazuridine-epimer
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice