TriangleNCT00585195 · OUTCOME
Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib Cycle 2 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, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1
What was measured
Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).
Analysis population: The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts (both low and high) and combined RP2D Cohort.
Groups in this outcome
Low Dose Escalation Cohort: Crizotinib 50 mg QD
Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
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 QD
Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
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 250 mg BID
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet 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.
High Dose Escalation Cohort: Crizotinib 300 mg QD
Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
High Dose Escalation Cohort: Crizotinib 400 mg QD
Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
High Dose Escalation Cohort: Crizotinib 500 mg QD
Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
High Dose Escalation Cohort: Crizotinib 650 mg QD
Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
High Dose Escalation Cohort: Crizotinib 800 mg QD
Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
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 50 mg QD | 3 |
| Low Dose Escalation Cohort: Crizotinib 100 mg QD | 3 |
| Low Dose Escalation Cohort: Crizotinib 200 mg QD | 5 |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 3 |
| Low Dose Escalation Cohort: Crizotinib 250 mg BID | 5 |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 3 |
| High Dose Escalation Cohort: Crizotinib 300 mg QD | 6 |
| High Dose Escalation Cohort: Crizotinib 400 mg QD | 3 |
| High Dose Escalation Cohort: Crizotinib 500 mg QD | 2 |
| High Dose Escalation Cohort: Crizotinib 650 mg QD | 4 |
| High Dose Escalation Cohort: Crizotinib 800 mg QD | 2 |
| RP2D Cohort: Crizotinib 250 mg | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Dose Escalation Cohort: Crizotinib 50 mg QD | 1.02 | Not reported | 1.00 | 4.00 | Not reported |
| Low Dose Escalation Cohort: Crizotinib 100 mg QD | 3.98 | Not reported | 2.00 | 4.02 | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg QD | 4.00 | Not reported | 2.00 | 4.17 | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 4.00 | Not reported | 3.95 | 4.00 | Not reported |
| Low Dose Escalation Cohort: Crizotinib 250 mg BID | 4.00 | Not reported | 4.00 | 6.00 | Not reported |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 4.05 | Not reported | 3.98 | 9.00 | Not reported |
| High Dose Escalation Cohort: Crizotinib 300 mg QD | 3.00 | Not reported | 1.00 | 5.95 | Not reported |
| High Dose Escalation Cohort: Crizotinib 400 mg QD | 4.00 | Not reported | 2.08 | 6.00 | Not reported |
| High Dose Escalation Cohort: Crizotinib 500 mg QD | 7.59 | Not reported | 6.18 | 9.00 | Not reported |
| High Dose Escalation Cohort: Crizotinib 650 mg QD | 4.30 | Not reported | 4.00 | 9.00 | Not reported |
| High Dose Escalation Cohort: Crizotinib 800 mg QD | 5.00 | Not reported | 4.00 | 6.00 | Not reported |
| RP2D Cohort: Crizotinib 250 mg | 4.00 | Not reported | 0.00 | 9.02 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.02
- group Id
- OG001
- lower Limit
- 2.00
- upper Limit
- 4.02
- value
- 3.98
- group Id
- OG002
- lower Limit
- 2.00
- upper Limit
- 4.17
- value
- 4.00
- group Id
- OG003
- lower Limit
- 3.95
- upper Limit
- 4.00
- value
- 4.00
- group Id
- OG004
- lower Limit
- 4.00
- upper Limit
- 6.00
- value
- 4.00
- group Id
- OG005
- lower Limit
- 3.98
- upper Limit
- 9.00
- value
- 4.05
- group Id
- OG006
- lower Limit
- 1.00
- upper Limit
- 5.95
- value
- 3.00
- group Id
- OG007
- lower Limit
- 2.08
- upper Limit
- 6.00
- value
- 4.00
- group Id
- OG008
- lower Limit
- 6.18
- upper Limit
- 9.00
- value
- 7.59
- group Id
- OG009
- lower Limit
- 4.00
- upper Limit
- 9.00
- value
- 4.30
- group Id
- OG010
- lower Limit
- 4.00
- upper Limit
- 6.00
- value
- 5.00
- group Id
- OG011
- lower Limit
- 0.00
- upper Limit
- 9.02
- value
- 4.00
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 18
- 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 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
- id
- OG000
- title
- Low Dose Escalation Cohort: Crizotinib 50 mg QD
- 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
- OG001
- 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 QD for up to 34 cycles (each cycle 28 days).
- id
- OG002
- title
- Low Dose Escalation Cohort: Crizotinib 200 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
- OG003
- title
- Low Dose Escalation Cohort: Crizotinib 200 mg BID
- description
- Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
- id
- OG004
- title
- Low Dose Escalation Cohort: Crizotinib 250 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
- OG005
- title
- Low Dose Escalation Cohort: Crizotinib 300 mg BID
- description
- Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
- id
- OG006
- title
- High Dose Escalation Cohort: Crizotinib 300 mg QD
- description
- Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
- id
- OG007
- title
- High Dose Escalation Cohort: Crizotinib 400 mg QD
- description
- Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
- id
- OG008
- title
- High Dose Escalation Cohort: Crizotinib 500 mg QD
- description
- Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
- id
- OG009
- title
- High Dose Escalation Cohort: Crizotinib 650 mg QD
- description
- Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
- id
- OG010
- title
- High Dose Escalation Cohort: Crizotinib 800 mg QD
- 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
- OG011
- title
- RP2D Cohort: Crizotinib 250 mg
- param Type
- MEDIAN
- population Description
- The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts (both low and high) and combined RP2D Cohort.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1
- title
- Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib Cycle 2 Day 1
- type
- PRIMARY
- unit Of Measure
- hour
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Preserved source evidence · Not medical advice