TriangleNCT02103478 · OUTCOME
Number of Participants With Transfusion Independence
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
Transfusion independence was calculated based on the number of transfusion-dependent participants at baseline who had no red blood cell or platelet transfusions for 56 consecutive days or more after treatment.
Analysis population: The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product and were transfusion-dependent at baseline. Number analyzed is the number of participants who were transfusion-dependent at baseline.
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 1 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 | 4 |
| Phase 1 Dose Escalation Cohort 2 | 2 |
| Phase 1 Dose Escalation Cohort 3 | 6 |
| Phase 1 Dose Escalation Cohort 4 | 5 |
| Phase 1 Dose Escalation Cohort 5 | 12 |
| Phase 2 Dose Confirmation | 29 |
| Phase 2 Fixed-Dose Combination | 21 |
Reported measurements
Red Blood Cell
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort 1 | 4 |
| Phase 1 Dose Escalation Cohort 2 | 2 |
| Phase 1 Dose Escalation Cohort 3 | 5 |
| Phase 1 Dose Escalation Cohort 4 | 4 |
| Phase 1 Dose Escalation Cohort 5 | 8 |
| Phase 2 Dose Confirmation | 22 |
| Phase 2 Fixed-Dose Combination | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Dose Confirmation | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Fixed-Dose Combination | 8 | Not reported | Not reported | Not reported | Not reported |
Platelet
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort 1 | 0 |
| Phase 1 Dose Escalation Cohort 2 | 0 |
| Phase 1 Dose Escalation Cohort 3 | 1 |
| Phase 1 Dose Escalation Cohort 4 | 1 |
| Phase 1 Dose Escalation Cohort 5 | 4 |
| Phase 2 Dose Confirmation | 7 |
| Phase 2 Fixed-Dose Combination | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Dose Confirmation | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Fixed-Dose Combination | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 22
- group Id
- OG006
- value
- 16
- units
- Participants
- title
- Red Blood Cell
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 5
- units
- Participants
- title
- Platelet
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 29
- group Id
- OG006
- value
- 21
- units
- Participants
- description
- Transfusion independence was calculated based on the number of transfusion-dependent participants at baseline who had no red blood cell or platelet transfusions for 56 consecutive days or more after treatment.
- 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 1 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 and were transfusion-dependent at baseline. Number analyzed is the number of participants who were transfusion-dependent at baseline.
- reporting Status
- POSTED
- time Frame
- Up to 32 months
- title
- Number of Participants With Transfusion Independence
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice