TriangleNCT00585195 · OUTCOME
Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram*hour per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7
What was measured
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0-inf).
Analysis population: Pharmacokinetic (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. "Overall number of participants analyzed (N)" signifies participants evaluable for this outcome measure (OM). Data for this OM was planned to be collected for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.
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 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 200 mg QD | 7 |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 2 |
| Low Dose Escalation Cohort: Crizotinib 250 mg BID | 8 |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 1 |
| High Dose Escalation Cohort: Crizotinib 300 mg QD | 5 |
| High Dose Escalation Cohort: Crizotinib 400 mg QD | 5 |
| High Dose Escalation Cohort: Crizotinib 500 mg QD | 2 |
| High Dose Escalation Cohort: Crizotinib 650 mg QD | 6 |
| High Dose Escalation Cohort: Crizotinib 800 mg QD | 8 |
| RP2D Cohort: Crizotinib 250 mg | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Dose Escalation Cohort: Crizotinib 50 mg QD | 274.43 | 22 | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg QD | 1378.05 | 144 | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 946.93 | 38 | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 250 mg BID | 1817.35 | 34 | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 2320.00 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 300 mg QD | 3457 | 42 | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 400 mg QD | 3078 | 119 | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 500 mg QD | 2107 | 53 | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 650 mg QD | 3979 | 39 | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 800 mg QD | 7547 | 76 | Not reported | Not reported | Not reported |
| RP2D Cohort: Crizotinib 250 mg | 2489.39 | 53 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 22
- value
- 274.43
- group Id
- OG001
- spread
- 144
- value
- 1378.05
- group Id
- OG002
- spread
- 38
- value
- 946.93
- group Id
- OG003
- spread
- 34
- value
- 1817.35
- group Id
- OG004
- value
- 2320.00
- group Id
- OG005
- spread
- 42
- value
- 3457
- group Id
- OG006
- spread
- 119
- value
- 3078
- group Id
- OG007
- spread
- 53
- value
- 2107
- group Id
- OG008
- spread
- 39
- value
- 3979
- group Id
- OG009
- spread
- 76
- value
- 7547
- group Id
- OG010
- spread
- 53
- value
- 2489.39
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 29
- units
- Participants
- description
- AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0-inf).
- dispersion Type
- Geometric Coefficient of Variation
- 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 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
- id
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- 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
- OG007
- 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
- OG008
- 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
- OG009
- 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
- OG010
- title
- RP2D Cohort: Crizotinib 250 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (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. "Overall number of participants analyzed (N)" signifies participants evaluable for this outcome measure (OM). Data for this OM was planned to be collected for individual arms of low and high dose escalation and combined RP2D Cohort excluding "Low Dose Escalation Cohort: Crizotinib 100 mg QD" arm.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7
- title
- Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7
- type
- PRIMARY
- unit Of Measure
- nanogram*hour per milliliter
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Preserved source evidence · Not medical advice