TriangleNCT01121588 · OUTCOME
Ctrough Ratios of PF-06260182 to Crizotinib on Day 1 of Cycles 2, 3 and 5
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Ratio
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose within -1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5
What was measured
Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. The ratio is calculated as: (PF-06260182 concentration/464.33)/(Crizotinib concentration/450.34), where 464.33 is molecular weight for PF-06260182 and 450.33 is molecular weight for Crizotinib.
Analysis population: Number of Participants Analyzed = participants who were enrolled and treated, had at least 1 PK blood sample collected, and were evaluable for steady-state Ctrough analysis. Number Analyzed = participants evaluable for this OM and had Ctrough data on the specific day.
Groups in this outcome
ALCL Arm
In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
IMT Arm
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
Other Tumors
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
| Group | Source count |
|---|---|
| ALCL Arm | 15 |
| IMT Arm | 8 |
| Other Tumors | 12 |
Reported measurements
Cycle 2 Day 1
| Group | Source count |
|---|---|
| ALCL Arm | 10 |
| IMT Arm | 6 |
| Other Tumors | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 0.323 | 15.2 | Not reported | Not reported | Not reported |
| IMT Arm | 0.249 | 25.0 | Not reported | Not reported | Not reported |
| Other Tumors | 0.190 | 32.7 | Not reported | Not reported | Not reported |
Cycle 3 Day 1
| Group | Source count |
|---|---|
| ALCL Arm | 11 |
| IMT Arm | 6 |
| Other Tumors | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 0.314 | 26.0 | Not reported | Not reported | Not reported |
| IMT Arm | 0.226 | 41.4 | Not reported | Not reported | Not reported |
| Other Tumors | 0.126 | 108 | Not reported | Not reported | Not reported |
Cycle 5 Day 1
| Group | Source count |
|---|---|
| ALCL Arm | 9 |
| IMT Arm | 7 |
| Other Tumors | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 0.326 | 28.3 | Not reported | Not reported | Not reported |
| IMT Arm | 0.270 | 27.7 | Not reported | Not reported | Not reported |
| Other Tumors | 0.243 | 28.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.2
- value
- 0.323
- group Id
- OG001
- spread
- 25.0
- value
- 0.249
- group Id
- OG002
- spread
- 32.7
- value
- 0.190
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 26.0
- value
- 0.314
- group Id
- OG001
- spread
- 41.4
- value
- 0.226
- group Id
- OG002
- spread
- 108
- value
- 0.126
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 28.3
- value
- 0.326
- group Id
- OG001
- spread
- 27.7
- value
- 0.270
- group Id
- OG002
- spread
- 28.0
- value
- 0.243
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- Cycle 5 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 12
- units
- Participants
- description
- Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection. The ratio is calculated as: (PF-06260182 concentration/464.33)/(Crizotinib concentration/450.34), where 464.33 is molecular weight for PF-06260182 and 450.33 is molecular weight for Crizotinib.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG000
- title
- ALCL Arm
- description
- In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG001
- title
- IMT Arm
- description
- In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG002
- title
- Other Tumors
- param Type
- GEOMETRIC_MEAN
- population Description
- Number of Participants Analyzed = participants who were enrolled and treated, had at least 1 PK blood sample collected, and were evaluable for steady-state Ctrough analysis. Number Analyzed = participants evaluable for this OM and had Ctrough data on the specific day.
- reporting Status
- POSTED
- time Frame
- Predose within -1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5
- title
- Ctrough Ratios of PF-06260182 to Crizotinib on Day 1 of Cycles 2, 3 and 5
- type
- SECONDARY
- unit Of Measure
- Ratio
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Preserved source evidence · Not medical advice