TriangleNCT01546038 · OUTCOME
Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - End of Treatment
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
- End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)
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. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.
Analysis population: PD analysis set: all enrolled participants in the Phase 2 Unfit 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 Unfit: Glasdegib 100 mg + LDAC (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).
Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)
AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder) | 17 |
| Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder) | 0.00 | Not reported | 0.00 | 45.00 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder) | 9.40 | Not reported | 0.00 | 52.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 45.00
- value
- 0.00
- group Id
- OG001
- lower Limit
- 0.00
- upper Limit
- 52.00
- value
- 9.40
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 18
- 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. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.
- 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).
- id
- OG000
- title
- Phase 2 Unfit: Glasdegib 100 mg + LDAC (Biomarker, Responder)
- description
- AML subjects who did not achieve CR, CRi, MLFS, PR, or PRi; and MDS subjects who did not achieve CR, mCR, PR or SD were defined as non-responders for best overall response.
- id
- OG001
- title
- Phase 2 Unfit: Glasdegib 100 mg+LDAC(Biomarker, Non-Responder)
- param Type
- MEDIAN
- population Description
- PD analysis set: all enrolled participants in the Phase 2 Unfit 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
- End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)
- title
- Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - End of Treatment
- type
- SECONDARY
- unit Of Measure
- pg/mL
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Preserved source evidence · Not medical advice