NCT01546038 · OUTCOME
Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction 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
- MEDIAN
- Unit
- pg/mL
- Interval / dispersion
- Full Range
- Time frame
- Induction Cycle 1/Day 10, 1 Hour Post dose
What was measured
Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.
Analysis population: PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample 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
IL-1β (Interleukin-1β)
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 8.50 | Not reported | 0.00 | 15.00 | Not reported |
|---|
IL-6
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 17.00 | Not reported | 0.00 | 7320.00 | Not reported |
|---|
Factor VII
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 292500 | Not reported | 45000 | 641000 | Not reported |
|---|
BDNF
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 300 | Not reported | 0 | 15000 | Not reported |
|---|
VEGF
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 69.00 | Not reported | 0.00 | 140.00 | Not reported |
|---|
MCP-1
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 594.00 | Not reported | 126.00 | 21200.00 | Not reported |
|---|
MMP-3
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 12000 | Not reported | 3000 | 93000 | Not reported |
|---|
IL-8
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 55.00 | Not reported | 0.00 | 8930.00 | Not reported |
|---|
IL-5
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 85.00 | Not reported | 0.00 | 2240.00 | Not reported |
|---|
ITAC
Values in pg/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.00 | Not reported | 0.00 | 46.00 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 15.00
- value
- 8.50
- title
- IL-1β (Interleukin-1β)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 7320.00
- value
- 17.00
- title
- IL-6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45000
- upper Limit
- 641000
- value
- 292500
- title
- Factor VII
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 15000
- value
- 300
- title
- BDNF
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 140.00
- value
- 69.00
- title
- VEGF
- categories
- measurements
- group Id
- OG000
- lower Limit
- 126.00
- upper Limit
- 21200.00
- value
- 594.00
- title
- MCP-1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3000
- upper Limit
- 93000
- value
- 12000
- title
- MMP-3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 8930.00
- value
- 55.00
- title
- IL-8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 2240.00
- value
- 85.00
- title
- IL-5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 46.00
- value
- 0.00
- title
- ITAC
- description
- Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.
- 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 the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.
- reporting Status
- POSTED
- time Frame
- Induction Cycle 1/Day 10, 1 Hour Post dose
- title
- Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction Cycle 1/Day 10
- type
- SECONDARY
- unit Of Measure
- pg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle