TriangleNCT02933320 · OUTCOME
Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- BI-1206 MAD (mg)
- Interval / dispersion
- Not reported
- Time frame
- Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.
What was measured
Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies.
Analysis population: Safety population
Groups in this outcome
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase
BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase
Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.
Part B: Arm1: BI-1206 Single Agent Expansion Phase
Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.
Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase
Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
| Group | Source count |
|---|---|
| Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 13 |
| Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | 1 |
| Part B: Arm1: BI-1206 Single Agent Expansion Phase | 0 |
| Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase | 100 | Not reported | Not reported | Not reported | Not reported |
| Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase | NA | Not reported | Not reported | Not reported | 50 mg BI-1206 given but not rituximab |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100
- comment
- 50 mg BI-1206 given but not rituximab
- group Id
- OG001
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies.
- groups
- description
- BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.
- id
- OG000
- title
- Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase
- description
- Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.
- id
- OG001
- title
- Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase
- description
- Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.
- id
- OG002
- title
- Part B: Arm1: BI-1206 Single Agent Expansion Phase
- description
- Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
- id
- OG003
- title
- Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.
- title
- Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody.
- type
- PRIMARY
- unit Of Measure
- BI-1206 MAD (mg)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice