NCT01546038 · OUTCOME
Cmax of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2020-03-03
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, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10
What was measured
Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, Cmax levels of both LDAC and Ara-U were 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 + LDAC
Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (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 twice daily (BID) on Days 1-10 of the 28-day cycles.
Phase 1B: Glasdegib 200 mg + LDAC
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 17 |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 6 |
|---|
Reported measurements
LDAC Cycle 1/Day 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 16 |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 6 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 58.50 | 58 | Not reported | Not reported | Not reported |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 100.1 | 29 | Not reported | Not reported | Not reported |
|---|
LDAC Cycle 1/Day 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 12 |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 6 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 63.01 | 88 | Not reported | Not reported | Not reported |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 132.5 | 39 | Not reported | Not reported | Not reported |
|---|
Ara-U Cycle 1/Day 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 17 |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 6 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 379.5 | 34 | Not reported | Not reported | Not reported |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 569.7 | 29 | Not reported | Not reported | Not reported |
|---|
Ara-U Cycle 1/Day 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 12 |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 6 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1B: Glasdegib 100 mg + LDAC | 452.2 | 36 | Not reported | Not reported | Not reported |
|---|
| Phase 1B: Glasdegib 200 mg + LDAC | 652.0 | 27 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 58
- value
- 58.50
- group Id
- OG001
- spread
- 29
- value
- 100.1
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- LDAC Cycle 1/Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 88
- value
- 63.01
- group Id
- OG001
- spread
- 39
- value
- 132.5
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- LDAC Cycle 1/Day 10
- categories
- measurements
- group Id
- OG000
- spread
- 34
- value
- 379.5
- group Id
- OG001
- spread
- 29
- value
- 569.7
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Ara-U Cycle 1/Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 36
- value
- 452.2
- group Id
- OG001
- spread
- 27
- value
- 652.0
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Ara-U Cycle 1/Day 10
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, Cmax levels of both LDAC and Ara-U were reported.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (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 twice daily (BID) on Days 1-10 of the 28-day cycles.
- id
- OG000
- title
- Phase 1B: Glasdegib 100 mg + LDAC
- 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 + LDAC
- 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, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10
- title
- Cmax of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10
- type
- SECONDARY
- unit Of Measure
- ng/mL
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