TriangleNCT01606878 · OUTCOME
Area Under the Concentration
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hr*ug/mL
- Interval / dispersion
- Full Range
- Time frame
- Up to 21 days
What was measured
Median (min, max) of the area under the concentration time curve for crizotinib assessed in course 1 at 1, 2, 4, 6-8 hours, and 15-21 days post-administration stratified by dose level and study part.
Analysis population: All Toxicity evaluable patients. There were no data for Part A Dose Level 2, Part B Dose Level 3, and Part D Dose Level 1.
Groups in this outcome
Part A Dose Level 1
Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
Part B Dose Level 1
Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
Part B Dose Level 2
Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
Part C Dose Level 1
Patients receive 165 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Part C Dose Level 2
Patients receive 215 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Part C Dose Level 3
Patients receive 280 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Part D Dose Level 2
Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Part PK Dose Level 2
Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Part A Dose Level 1 | 5 |
| Part B Dose Level 1 | 3 |
| Part B Dose Level 2 | 3 |
| Part C Dose Level 1 | 1 |
| Part C Dose Level 2 | 5 |
| Part C Dose Level 3 | 1 |
| Part D Dose Level 2 | 2 |
| Part PK Dose Level 2 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Level 1 | 3792.5 | Not reported | 1808.8 | 5520.3 | Not reported |
| Part B Dose Level 1 | 1549.3 | Not reported | 811.4 | 2544.3 | Not reported |
| Part B Dose Level 2 | 4070.5 | Not reported | 3588.0 | 10145.9 | Not reported |
| Part C Dose Level 1 | 1612 | Not reported | 1612.0 | 1612.0 | Not reported |
| Part C Dose Level 2 | 3796.6 | Not reported | 2976.0 | 7299.3 | Not reported |
| Part C Dose Level 3 | 7462.8 | Not reported | 7462.8 | 7462.8 | Not reported |
| Part D Dose Level 2 | 3248 | Not reported | 3109.9 | 3386.1 | Not reported |
| Part PK Dose Level 2 | 8881.3 | Not reported | 5701.6 | 12061.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1808.8
- upper Limit
- 5520.3
- value
- 3792.5
- group Id
- OG001
- lower Limit
- 811.4
- upper Limit
- 2544.3
- value
- 1549.3
- group Id
- OG002
- lower Limit
- 3588.0
- upper Limit
- 10145.9
- value
- 4070.5
- group Id
- OG003
- lower Limit
- 1612.0
- upper Limit
- 1612.0
- value
- 1612
- group Id
- OG004
- lower Limit
- 2976.0
- upper Limit
- 7299.3
- value
- 3796.6
- group Id
- OG005
- lower Limit
- 7462.8
- upper Limit
- 7462.8
- value
- 7462.8
- group Id
- OG006
- lower Limit
- 3109.9
- upper Limit
- 3386.1
- value
- 3248
- group Id
- OG007
- lower Limit
- 5701.6
- upper Limit
- 12061.0
- value
- 8881.3
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- units
- Participants
- description
- Median (min, max) of the area under the concentration time curve for crizotinib assessed in course 1 at 1, 2, 4, 6-8 hours, and 15-21 days post-administration stratified by dose level and study part.
- dispersion Type
- Full Range
- groups
- description
- Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- id
- OG000
- title
- Part A Dose Level 1
- description
- Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- id
- OG001
- title
- Part B Dose Level 1
- description
- Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- id
- OG002
- title
- Part B Dose Level 2
- description
- Patients receive 165 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Part C Dose Level 1
- description
- Patients receive 215 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Part C Dose Level 2
- description
- Patients receive 280 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG005
- title
- Part C Dose Level 3
- description
- Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG006
- title
- Part D Dose Level 2
- description
- Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG007
- title
- Part PK Dose Level 2
- param Type
- MEDIAN
- population Description
- All Toxicity evaluable patients. There were no data for Part A Dose Level 2, Part B Dose Level 3, and Part D Dose Level 1.
- reporting Status
- POSTED
- time Frame
- Up to 21 days
- title
- Area Under the Concentration
- type
- PRIMARY
- unit Of Measure
- hr*ug/mL
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Preserved source evidence · Not medical advice