TriangleNCT02303821 · OUTCOME
Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 35 days
What was measured
A DLT was defined as any of the following toxicities assessed by the investigator as possibly, probably, or definitely attributable to carfilzomib, with protocol defined exclusions: Any Grade 4 nonhematologic toxicity, ≥ Grade 4 neutropenia or ≥ Grade 3 thrombocytopenia.
Analysis population: Phase 1b DLT Evaluable Analysis Set: All participants who received all planned dose of carfilzomib and the chemotherapy backbone per protocol during the lead-in window and induction cycle, or received at least one dose of carfilzomib and the chemotherapy backbone per protocol and experienced a DLT prior to completion of the lead-in window or induction cycle, or as clinically indicated.
Groups in this outcome
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
| Group | Source count |
|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 4 |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 4 |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 2 |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 4 |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 3 |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 8 |
Reported measurements
Haemolytic uraemic syndrome
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
Platelet count decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
Pulmonary haemorrhage
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Haemolytic uraemic syndrome
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- title
- Platelet count decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- title
- Pulmonary haemorrhage
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 8
- units
- Participants
- description
- A DLT was defined as any of the following toxicities assessed by the investigator as possibly, probably, or definitely attributable to carfilzomib, with protocol defined exclusions: Any Grade 4 nonhematologic toxicity, ≥ Grade 4 neutropenia or ≥ Grade 3 thrombocytopenia.
- groups
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG000
- title
- Phase 1b: Dose Escalation 1 (20 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG001
- title
- Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG002
- title
- Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG003
- title
- Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG004
- title
- Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG005
- title
- Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Phase 1b DLT Evaluable Analysis Set: All participants who received all planned dose of carfilzomib and the chemotherapy backbone per protocol during the lead-in window and induction cycle, or received at least one dose of carfilzomib and the chemotherapy backbone per protocol and experienced a DLT prior to completion of the lead-in window or induction cycle, or as clinically indicated.
- reporting Status
- POSTED
- time Frame
- Up to approximately 35 days
- title
- Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice