TriangleNCT02103478 · OUTCOME
Number of Participants With Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 32 months
What was measured
Overall survival was defined as the number of days from the day the participant received the first dose of IV decitabine, oral decitabine + E7727, or the FDC tablet to the date of death, regardless of cause.
Analysis population: The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.
Groups in this outcome
Phase 1 Dose Escalation Cohort 1
Starting cohort 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
Starting cohort 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
Starting cohort 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
Starting cohort 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
Starting cohort 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 | 7 |
| 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 | 50 |
| Phase 2 Fixed-Dose Combination | 30 |
Reported measurements
Source class 1
Censored
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 15 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Dose Confirmation | 26 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Fixed-Dose Combination | 14 | Not reported | Not reported | Not reported | Not reported |
Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Dose Confirmation | 24 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Fixed-Dose Combination | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 26
- group Id
- OG006
- value
- 14
- title
- Censored
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 24
- group Id
- OG006
- value
- 16
- title
- Event
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 50
- group Id
- OG006
- value
- 30
- units
- Participants
- description
- Overall survival was defined as the number of days from the day the participant received the first dose of IV decitabine, oral decitabine + E7727, or the FDC tablet to the date of death, regardless of cause.
- groups
- description
- Starting cohort 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
- Starting cohort 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
- Starting cohort 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
- Starting cohort 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
- Starting cohort 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
- COUNT_OF_PARTICIPANTS
- population Description
- The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.
- reporting Status
- POSTED
- time Frame
- Up to 32 months
- title
- Number of Participants With Overall Survival
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice