TriangleNCT01546038 · OUTCOME
Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B
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
- Baseline (Cycle 1/Day 1 pre-dose for Glasdegib + LDAC and Glasdegib + Decitabine Arms; Induction Cycle 1/Day -3 pre-dose for Glasdegib +Cytarabine/Daunorubicin Arm)
What was measured
Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response in Arm C are reported. Baseline levels statistically associated with best overall response was only seen in SDF-1 (stromal cell-derived factor 1) in glasdegib+cytarabine/daunorubicin arm.
Analysis population: PD analysis set: all enrolled participants in the Phase 1B 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 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)
AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)
AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
| Group | Source count |
|---|---|
| Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder) | 14 |
| Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder) | 2275.00 | Not reported | 1600.00 | 3700.00 | Not reported |
| Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder) | 3275.00 | Not reported | 1950.00 | 4730.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1600.00
- upper Limit
- 3700.00
- value
- 2275.00
- group Id
- OG001
- lower Limit
- 1950.00
- upper Limit
- 4730.00
- value
- 3275.00
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response in Arm C are reported. Baseline levels statistically associated with best overall response was only seen in SDF-1 (stromal cell-derived factor 1) in glasdegib+cytarabine/daunorubicin arm.
- dispersion Type
- Full Range
- groups
- description
- AML subjects who achieved CR, CRi, MLFS, PR, or PRi (AML investigator reported best overall response), and MDS subjects who achieved CR, mCR, PR, or SD (MDS investigator reported best overall response). Dauno is short for daunorubicin.
- id
- OG000
- title
- Phase 1B: Glasdegib + Cytarabine/Dauno (Biomarker, Responder)
- description
- AML participants who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS participants who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response. Dauno is short for daunorubicin.
- id
- OG001
- title
- Phase 1B: Glasdegib+Cytarabine/Dauno(Biomarker,Non-Responder)
- param Type
- MEDIAN
- population Description
- PD analysis set: all enrolled participants in the Phase 1B 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
- Baseline (Cycle 1/Day 1 pre-dose for Glasdegib + LDAC and Glasdegib + Decitabine Arms; Induction Cycle 1/Day -3 pre-dose for Glasdegib +Cytarabine/Daunorubicin Arm)
- title
- Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B
- type
- SECONDARY
- unit Of Measure
- pg/mL
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Preserved source evidence · Not medical advice