TriangleNCT01546038 · OUTCOME
Tmax of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 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
- Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2
Analysis population: PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.
Groups in this outcome
Phase 1B: Glasdegib 100 mg + Decitabine
Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
Phase 1B: Glasdegib 200 mg + Decitabine
Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
| Group | Source count |
|---|---|
| Phase 1B: Glasdegib 100 mg + Decitabine | 4 |
| Phase 1B: Glasdegib 200 mg + Decitabine | 3 |
Reported measurements
Cycle 1/Day 1
| Group | Source count |
|---|---|
| Phase 1B: Glasdegib 100 mg + Decitabine | 3 |
| Phase 1B: Glasdegib 200 mg + Decitabine | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1B: Glasdegib 100 mg + Decitabine | 0.75 | Not reported | 0.50 | 1.0 | Not reported |
| Phase 1B: Glasdegib 200 mg + Decitabine | 0.53 | Not reported | 0.52 | 0.75 | Not reported |
Cycle 1/Day 2
| Group | Source count |
|---|---|
| Phase 1B: Glasdegib 100 mg + Decitabine | 3 |
| Phase 1B: Glasdegib 200 mg + Decitabine | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1B: Glasdegib 100 mg + Decitabine | 0.58 | Not reported | 0.53 | 0.95 | Not reported |
| Phase 1B: Glasdegib 200 mg + Decitabine | 0.53 | Not reported | 0.52 | 1.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.50
- upper Limit
- 1.0
- value
- 0.75
- group Id
- OG001
- lower Limit
- 0.52
- upper Limit
- 0.75
- value
- 0.53
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1/Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.53
- upper Limit
- 0.95
- value
- 0.58
- group Id
- OG001
- lower Limit
- 0.52
- upper Limit
- 1.3
- value
- 0.53
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 1/Day 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.
- id
- OG000
- title
- Phase 1B: Glasdegib 100 mg + Decitabine
- description
- Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.
- id
- OG001
- title
- Phase 1B: Glasdegib 200 mg + Decitabine
- param Type
- MEDIAN
- population Description
- PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2
- title
- Tmax of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2
- type
- SECONDARY
- unit Of Measure
- Hours
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Preserved source evidence · Not medical advice