NCT01546038 · OUTCOME
Ratios of mRNA Levels to Baseline at Phase 2 Fit - Induction Cycle 1/Day 3
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
- MEDIAN
- Unit
- ratio
- Interval / dispersion
- Full Range
- Time frame
- Baseline (Induction Cycle 1/Day -3 pre-dose); Induction Cycle 1/Day 3, 1 Hour Post dose
What was measured
Whole blood mRNA analyses were performed on 21 mRNA candidates. Values showing statistically significant, ≥2-fold differences compared with baseline are reported here. CDKN1A: cyclin-dependent kinase inhibitor 1A; SMO: mRNA encoding the glasdegib target Smoothened; PTCH2: Patched 2; MYCN: Neuroblastoma Myc oncogene.
Analysis population: PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.
Groups in this outcome
Phase 2 Fit: 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.
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 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 62 |
|---|
Reported measurements
CDKN1A
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 54 |
|---|
Values in ratio · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 2.40 | Not reported | 0.08 | 53.17 | Not reported |
|---|
SMO
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 18 |
|---|
Values in ratio · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 4.80 | Not reported | 0.06 | 51.22 | Not reported |
|---|
PTCH2
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 10 |
|---|
Values in ratio · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.60 | Not reported | 0.03 | 2.66 | Not reported |
|---|
MYCN
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 38 |
|---|
Values in ratio · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.20 | Not reported | 0.00 | 248.53 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.08
- upper Limit
- 53.17
- value
- 2.40
- title
- CDKN1A
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.06
- upper Limit
- 51.22
- value
- 4.80
- title
- SMO
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 2.66
- value
- 0.60
- title
- PTCH2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 248.53
- value
- 0.20
- title
- MYCN
- description
- Whole blood mRNA analyses were performed on 21 mRNA candidates. Values showing statistically significant, ≥2-fold differences compared with baseline are reported here. CDKN1A: cyclin-dependent kinase inhibitor 1A; SMO: mRNA encoding the glasdegib target Smoothened; PTCH2: Patched 2; MYCN: Neuroblastoma Myc oncogene.
- dispersion Type
- Full Range
- 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 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
- param Type
- MEDIAN
- population Description
- PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.
- reporting Status
- POSTED
- time Frame
- Baseline (Induction Cycle 1/Day -3 pre-dose); Induction Cycle 1/Day 3, 1 Hour Post dose
- title
- Ratios of mRNA Levels to Baseline at Phase 2 Fit - Induction Cycle 1/Day 3
- type
- SECONDARY
- unit Of Measure
- ratio
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