TriangleNCT01546038 · OUTCOME
Cmax of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3
What was measured
Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. Cmax values of daunorubicin and daunorubicinol are reported.
Analysis population: PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.
Groups in this outcome
Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
| Group | Source count |
|---|---|
| Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin | 15 |
| Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin | 6 |
Reported measurements
Daunorubicin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin | 275.3 | 153 | Not reported | Not reported | Not reported |
| Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin | 341.0 | 82 | Not reported | Not reported | Not reported |
Daunorubicinol
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin | 195.4 | 139 | Not reported | Not reported | Not reported |
| Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin | 233.4 | 46 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 153
- value
- 275.3
- group Id
- OG001
- spread
- 82
- value
- 341.0
- title
- Daunorubicin
- categories
- measurements
- group Id
- OG000
- spread
- 139
- value
- 195.4
- group Id
- OG001
- spread
- 46
- value
- 233.4
- title
- Daunorubicinol
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. Cmax values of daunorubicin and daunorubicinol are reported.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
- id
- OG000
- title
- Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin
- description
- Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 200 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.
- id
- OG001
- title
- Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin
- param Type
- GEOMETRIC_MEAN
- population Description
- PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3
- title
- Cmax of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice