TriangleNCT00261846 · OUTCOME
Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- 6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15
What was measured
CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the CD3+ (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using FACS flow cytometry. NA = not estimable.
Analysis population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' signifies number of participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time points for each arm group respectively.
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) | 1 |
| Bosutinib 500 mg (Part 1) | 3 |
| Bosutinib 600 mg (Part 1) | 9 |
Reported measurements
Day 1: post-dose (n=1, 1, 9)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | -34.66 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 500 mg (Part 1) | 287.52 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 600 mg (Part 1) | 97.79 | 283.61 | Not reported | Not reported | Not reported |
Day 8: pre-dose (n=1, 1, 9)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | 562.48 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 500 mg (Part 1) | 170.83 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 600 mg (Part 1) | 3.88 | 128.97 | Not reported | Not reported | Not reported |
Day 8: post-dose (n=1, 1, 9)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | 528.62 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 500 mg (Part 1) | 429.79 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 600 mg (Part 1) | 143.57 | 289.18 | Not reported | Not reported | Not reported |
Day 15: pre-dose (n=1, 2, 7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | 177.87 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 500 mg (Part 1) | -44.64 | 8.56 | Not reported | Not reported | Not reported |
| Bosutinib 600 mg (Part 1) | 119.23 | 170.91 | Not reported | Not reported | Not reported |
Day 15: post-dose (n=1, 3, 7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | -49.85 | NA | Not reported | Not reported | Standard deviation was not estimable since only 1 participant was evaluable. |
| Bosutinib 500 mg (Part 1) | -21.13 | 57.91 | Not reported | Not reported | Not reported |
| Bosutinib 600 mg (Part 1) | 138.45 | 278.24 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG000
- spread
- NA
- value
- -34.66
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG001
- spread
- NA
- value
- 287.52
- group Id
- OG002
- spread
- 283.61
- value
- 97.79
- title
- Day 1: post-dose (n=1, 1, 9)
- categories
- measurements
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG000
- spread
- NA
- value
- 562.48
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG001
- spread
- NA
- value
- 170.83
- group Id
- OG002
- spread
- 128.97
- value
- 3.88
- title
- Day 8: pre-dose (n=1, 1, 9)
- categories
- measurements
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG000
- spread
- NA
- value
- 528.62
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG001
- spread
- NA
- value
- 429.79
- group Id
- OG002
- spread
- 289.18
- value
- 143.57
- title
- Day 8: post-dose (n=1, 1, 9)
- categories
- measurements
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG000
- spread
- NA
- value
- 177.87
- group Id
- OG001
- spread
- 8.56
- value
- -44.64
- group Id
- OG002
- spread
- 170.91
- value
- 119.23
- title
- Day 15: pre-dose (n=1, 2, 7)
- categories
- measurements
- comment
- Standard deviation was not estimable since only 1 participant was evaluable.
- group Id
- OG000
- spread
- NA
- value
- -49.85
- group Id
- OG001
- spread
- 57.91
- value
- -21.13
- group Id
- OG002
- spread
- 278.24
- value
- 138.45
- title
- Day 15: post-dose (n=1, 3, 7)
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the CD3+ (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using FACS flow cytometry. NA = not estimable.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' signifies number of participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time points for each arm group respectively.
- reporting Status
- POSTED
- time Frame
- 6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15
- title
- Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice