TriangleNCT01957644 · OUTCOME
Percentage of Patients With Objective Response (OR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From randomisation until data cut-off (16Dec2016); up to 159 weeks
What was measured
OR was defined as best overall response of complete remission (CR) or partial remission (PR) defined according to the International Working Group (IWG) 2006 criteria. Complete remission (CR): * Bone marrow: \<5 % myeloblasts with normal maturation of all cell lines\* * Persistent dysplasia will be noted\* * Peripheral blood: * hemoglobin (Hgb) \> 11 Grams Per Decilitre (g/dL) * Platelets \>100 x 109/L * Neutrophils \> 1.0 x 109/L * Blasts 0 % \*Dysplastic changes should consider the normal range of dysplastic changes Partial remission (PR): All CR criteria if abnormal before treatment except: * Bone marrow blasts decreased by \>50% to pre-treatment but still \>5% * Cellularity and morphology not relevant
Analysis population: Efficacy set (ES): All the treated patients without any protocol violations related to efficacy
Groups in this outcome
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
| Group | Source count |
|---|---|
| Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | 6 |
| Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | 5 |
| Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | 1 |
| Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | 2 |
| Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1 | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1 | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1 | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2 | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 20.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- units
- Participants
- description
- OR was defined as best overall response of complete remission (CR) or partial remission (PR) defined according to the International Working Group (IWG) 2006 criteria. Complete remission (CR): * Bone marrow: \<5 % myeloblasts with normal maturation of all cell lines\* * Persistent dysplasia will be noted\* * Peripheral blood: * hemoglobin (Hgb) \> 11 Grams Per Decilitre (g/dL) * Platelets \>100 x 109/L * Neutrophils \> 1.0 x 109/L * Blasts 0 % \*Dysplastic changes should consider the normal range of dysplastic changes Partial remission (PR): All CR criteria if abnormal before treatment except: * Bone marrow blasts decreased by \>50% to pre-treatment but still \>5% * Cellularity and morphology not relevant
- groups
- description
- Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
- id
- OG000
- title
- Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
- description
- Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
- id
- OG001
- title
- Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
- description
- Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
- id
- OG002
- title
- Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
- description
- Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
- id
- OG003
- title
- Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
- description
- Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
- id
- OG004
- title
- Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
- param Type
- NUMBER
- population Description
- Efficacy set (ES): All the treated patients without any protocol violations related to efficacy
- reporting Status
- POSTED
- time Frame
- From randomisation until data cut-off (16Dec2016); up to 159 weeks
- title
- Percentage of Patients With Objective Response (OR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice