TriangleNCT00585195 · OUTCOME
Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1
What was measured
Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).
Analysis population: PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be collected for low dose escalation cohorts (excluding Crizotinib 50 mg QD, Crizotinib 200 mg QD and Crizotinib 250 mg BID arms) and combined RP2D cohort and was not planned to be collected for high dose escalation cohort.
Groups in this outcome
Low Dose Escalation Cohort: Crizotinib 100 mg QD
Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
Low Dose Escalation Cohort: Crizotinib 200 mg BID
Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
Low Dose Escalation Cohort: Crizotinib 300 mg BID
Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
RP2D Cohort: Crizotinib 250 mg
Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
| Group | Source count |
|---|---|
| Low Dose Escalation Cohort: Crizotinib 100 mg QD | 4 |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 2 |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 5 |
| RP2D Cohort: Crizotinib 250 mg | 98 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Dose Escalation Cohort: Crizotinib 100 mg QD | 2.52 | Not reported | 1.00 | 4.02 | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 4.00 | Not reported | 4.00 | 4.00 | Not reported |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 4.00 | Not reported | 2.05 | 8.02 | Not reported |
| RP2D Cohort: Crizotinib 250 mg | 4.05 | Not reported | 1.00 | 9.08 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 4.02
- value
- 2.52
- group Id
- OG001
- lower Limit
- 4.00
- upper Limit
- 4.00
- value
- 4.00
- group Id
- OG002
- lower Limit
- 2.05
- upper Limit
- 8.02
- value
- 4.00
- group Id
- OG003
- lower Limit
- 1.00
- upper Limit
- 9.08
- value
- 4.05
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 98
- units
- Participants
- description
- Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).
- dispersion Type
- Full Range
- groups
- description
- Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
- id
- OG000
- title
- Low Dose Escalation Cohort: Crizotinib 100 mg QD
- description
- Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
- id
- OG001
- title
- Low Dose Escalation Cohort: Crizotinib 200 mg BID
- description
- Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
- id
- OG002
- title
- Low Dose Escalation Cohort: Crizotinib 300 mg BID
- description
- Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
- id
- OG003
- title
- RP2D Cohort: Crizotinib 250 mg
- param Type
- MEDIAN
- population Description
- PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be collected for low dose escalation cohorts (excluding Crizotinib 50 mg QD, Crizotinib 200 mg QD and Crizotinib 250 mg BID arms) and combined RP2D cohort and was not planned to be collected for high dose escalation cohort.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1
- title
- Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Cycle 1 Day 1
- type
- PRIMARY
- unit Of Measure
- hour
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Preserved source evidence · Not medical advice