TriangleNCT00261846 · OUTCOME
Maximum Tolerated Dose (MTD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg
- Interval / dispersion
- Not reported
- Time frame
- Part 1 Baseline up to Day 28
What was measured
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1). NA = not estimable.
Analysis population: Safety population included all participants who received at least 1 dose of study medication
Groups in this outcome
Bosutinib 400 mg (Part 1)
Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
Bosutinib 500 mg (Part 1)
Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
Bosutinib 600 mg (Part 1)
Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
| Group | Source count |
|---|---|
| Bosutinib 400 mg (Part 1) | 3 |
| Bosutinib 500 mg (Part 1) | 3 |
| Bosutinib 600 mg (Part 1) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | NA | Not reported | Not reported | Not reported | MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2. |
| Bosutinib 500 mg (Part 1) | NA | Not reported | Not reported | Not reported | MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2. |
| Bosutinib 600 mg (Part 1) | NA | Not reported | Not reported | Not reported | MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2. |
Complete source fields
- classes
- categories
- measurements
- comment
- MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.
- group Id
- OG000
- value
- NA
- comment
- MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.
- group Id
- OG001
- value
- NA
- comment
- MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.
- group Id
- OG002
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- units
- Participants
- description
- MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1). NA = not estimable.
- groups
- description
- Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
- id
- OG000
- title
- Bosutinib 400 mg (Part 1)
- description
- Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
- id
- OG001
- title
- Bosutinib 500 mg (Part 1)
- description
- Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
- id
- OG002
- title
- Bosutinib 600 mg (Part 1)
- param Type
- NUMBER
- population Description
- Safety population included all participants who received at least 1 dose of study medication
- reporting Status
- POSTED
- time Frame
- Part 1 Baseline up to Day 28
- title
- Maximum Tolerated Dose (MTD)
- type
- PRIMARY
- unit Of Measure
- mg
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Preserved source evidence · Not medical advice