TriangleNCT02103478 · OUTCOME
Time to Maximum Observed Plasma Concentration (Tmax) 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
- 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 maximum observed plasma concentration. PK parameters are reported for the dose escalation stage by cohort in Phase 1 and the 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 | 47 |
| Phase 2 Fixed-Dose Combination | 30 |
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 | 47 |
| Phase 2 Fixed-Dose Combination | 29 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 3 | Not reported | 2 | 4 | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 3 | Not reported | 2 | 4 | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 3 | Not reported | 3 | 4 | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 3 | Not reported | 2 | 6 | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 3 | Not reported | 2 | 6 | Not reported |
| Phase 2 Dose Confirmation | 3 | Not reported | 1.50 | 4.08 | Not reported |
| Phase 2 Fixed-Dose Combination | 3 | Not reported | 2.00 | 7.18 | 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 | 6 |
| Phase 1 Dose Escalation Cohort 4 | 6 |
| Phase 1 Dose Escalation Cohort 5 | 19 |
| Phase 2 Dose Confirmation | 47 |
| Phase 2 Fixed-Dose Combination | 29 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 3 | Not reported | 2 | 4 | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 3 | Not reported | 2 | 3 | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 3 | Not reported | 3 | 4 | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 3 | Not reported | 2 | 6 | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 3 | Not reported | 2 | 6 | Not reported |
| Phase 2 Dose Confirmation | 3 | Not reported | 1.50 | 6.17 | Not reported |
| Phase 2 Fixed-Dose Combination | 3.05 | Not reported | 2.00 | 7.20 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- group Id
- OG002
- lower Limit
- 3
- upper Limit
- 4
- value
- 3
- group Id
- OG003
- lower Limit
- 2
- upper Limit
- 6
- value
- 3
- group Id
- OG004
- lower Limit
- 2
- upper Limit
- 6
- value
- 3
- group Id
- OG005
- lower Limit
- 1.50
- upper Limit
- 4.08
- value
- 3
- group Id
- OG006
- lower Limit
- 2.00
- upper Limit
- 7.18
- value
- 3
- 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
- 47
- group Id
- OG006
- value
- 29
- units
- Participants
- title
- Cedazuridine
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 3
- value
- 3
- group Id
- OG002
- lower Limit
- 3
- upper Limit
- 4
- value
- 3
- group Id
- OG003
- lower Limit
- 2
- upper Limit
- 6
- value
- 3
- group Id
- OG004
- lower Limit
- 2
- upper Limit
- 6
- value
- 3
- group Id
- OG005
- lower Limit
- 1.50
- upper Limit
- 6.17
- value
- 3
- group Id
- OG006
- lower Limit
- 2.00
- upper Limit
- 7.20
- value
- 3.05
- 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
- 47
- group Id
- OG006
- value
- 29
- 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
- 47
- group Id
- OG006
- value
- 30
- units
- Participants
- description
- Tmax is the time to maximum observed plasma concentration. PK parameters are reported for the dose escalation stage by cohort in Phase 1 and the dose confirmation and fixed-dose combination stages in Phase 2.
- dispersion Type
- Full Range
- 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
- 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 Cedazuridine (E7727) and Cedazuridine-epimer
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice