TriangleNCT00585195 · OUTCOME
Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAES) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- up to 189 Months
What was measured
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events. TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration.
Analysis population: SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.
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: ROS1-Positive NSCLC: Crizotinib 250
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days)
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).
RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).
RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
RP2D Cohort: Enriched Other: Crizotinib 250 mg
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).
RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole
Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16.
RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after food.
RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam
Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID with or without food from Day 1 Cycle 1 up to 133 cycles (each cycle 28 days). Participants also received single 2 mg oral dose of Midazolam on Day -7 and another single 2-mg oral dose of Midazolam concurrently with Crizotinib on Cycle 2 Day 1
| Group | Source count |
|---|---|
| Low Dose Escalation Cohort: Crizotinib 50 mg QD | 3 |
| Low Dose Escalation Cohort: Crizotinib 100 mg QD | 4 |
| Low Dose Escalation Cohort: Crizotinib 200 mg QD | 8 |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 7 |
| Low Dose Escalation Cohort: Crizotinib 250 mg BID | 8 |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 6 |
| High Dose Escalation Cohort: Crizotinib 300 mg QD | 6 |
| High Dose Escalation Cohort: Crizotinib 400 mg QD | 5 |
| High Dose Escalation Cohort: Crizotinib 500 mg QD | 3 |
| High Dose Escalation Cohort: Crizotinib 650 mg QD | 6 |
| High Dose Escalation Cohort: Crizotinib 800 mg QD | 9 |
| RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 | 53 |
| RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg | 85 |
| RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg | 41 |
| RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg | 48 |
| RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg | 18 |
| RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg | 154 |
| RP2D Cohort: Enriched Other: Crizotinib 250 mg | 66 |
| RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole | 18 |
| RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin | 18 |
| RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam | 12 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Dose Escalation Cohort: Crizotinib 50 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 100 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg QD | 8 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 7 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 250 mg BID | 8 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 300 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 400 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 500 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 650 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 800 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 | 53 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg | 85 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg | 41 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg | 47 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg | 18 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg | 154 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Enriched Other: Crizotinib 250 mg | 66 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole | 18 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin | 18 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam | 12 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low Dose Escalation Cohort: Crizotinib 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 200 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 250 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Low Dose Escalation Cohort: Crizotinib 300 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 300 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 400 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 500 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 650 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| High Dose Escalation Cohort: Crizotinib 800 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 | 24 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg | 54 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg | 25 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg | 22 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg | 9 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg | 75 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Enriched Other: Crizotinib 250 mg | 29 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg +Itraconazole | 7 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin | 6 | Not reported | Not reported | Not reported | Not reported |
| RP2D Cohort: Midazolam Interaction: Crizotinib 250 mg +Midazolam | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 53
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 24
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 53
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events. TEAEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration.
- 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 (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days)
- id
- OG011
- title
- RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.
- reporting Status
- POSTED
- time Frame
- up to 189 Months
- title
- Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAES) and Serious Adverse Events (SAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice