TriangleNCT00585195 · OUTCOME
Recommended Phase 2 Dose (RP2D) Cohort: Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until PD or death, whichever occurred first (up to 172 months)
What was measured
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PD: \>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Analysis population: SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.
Groups in this outcome
RP2D Cohort: ROS1-Positive 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 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-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).
| Group | Source count |
|---|---|
| RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg | 53 |
| RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg | 85 |
| RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg | 41 |
| RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg | 119 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg | 19.3 | Not reported | 15.2 | 39.1 | Not reported |
| RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg | 7.6 | Not reported | 5.6 | 9.1 | Not reported |
| RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg | 4.0 | Not reported | 1.9 | 6.9 | Not reported |
| RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg | 10.0 | Not reported | 8.2 | 14.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.2
- upper Limit
- 39.1
- value
- 19.3
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 9.1
- value
- 7.6
- group Id
- OG002
- lower Limit
- 1.9
- upper Limit
- 6.9
- value
- 4.0
- group Id
- OG003
- lower Limit
- 8.2
- upper Limit
- 14.7
- value
- 10.0
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 85
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 119
- units
- Participants
- description
- Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PD: \>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- title
- RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg
- 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 55 cycles (each cycle 28 days).
- id
- OG001
- title
- RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg
- 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 101 cycles (each cycle 28 days).
- id
- OG002
- title
- RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg
- description
- 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).
- id
- OG003
- title
- RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg
- param Type
- MEDIAN
- population Description
- SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.
- reporting Status
- POSTED
- time Frame
- From randomization until PD or death, whichever occurred first (up to 172 months)
- title
- Recommended Phase 2 Dose (RP2D) Cohort: Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice