TriangleNCT02393248 · OUTCOME
Part 2: Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 126 days
What was measured
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Analysis population: Efficacy Evaluable Population: all enrolled participants who received at least 1 dose of study drug
Groups in this outcome
Part 2: Intermittent Pemigatinib 9 mg QD
Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Part 2: Intermittent Pemigatinib 13.5 mg QD
Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
Part 2: Continuous Pemigatinib 9 mg QD
Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
Part 2: Continuous Pemigatinib 13.5 mg QD
Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
Part 2: Continuous Pemigatinib 20 mg QD
Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
| Group | Source count |
|---|---|
| Part 2: Intermittent Pemigatinib 9 mg QD | 4 |
| Part 2: Intermittent Pemigatinib 13.5 mg QD | 44 |
| Part 2: Continuous Pemigatinib 9 mg QD | 5 |
| Part 2: Continuous Pemigatinib 13.5 mg QD | 20 |
| Part 2: Continuous Pemigatinib 20 mg QD | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Intermittent Pemigatinib 9 mg QD | 25.0 | Not reported | 0.6 | 80.6 | Not reported |
| Part 2: Intermittent Pemigatinib 13.5 mg QD | 4.5 | Not reported | 0.6 | 15.5 | Not reported |
| Part 2: Continuous Pemigatinib 9 mg QD | 0.0 | Not reported | 0.0 | 52.2 | Not reported |
| Part 2: Continuous Pemigatinib 13.5 mg QD | 30.0 | Not reported | 11.9 | 54.3 | Not reported |
| Part 2: Continuous Pemigatinib 20 mg QD | 0.0 | Not reported | 0.0 | 45.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 80.6
- value
- 25.0
- group Id
- OG001
- lower Limit
- 0.6
- upper Limit
- 15.5
- value
- 4.5
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0.0
- group Id
- OG003
- lower Limit
- 11.9
- upper Limit
- 54.3
- value
- 30.0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 45.9
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 6
- units
- Participants
- description
- ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
- id
- OG000
- title
- Part 2: Intermittent Pemigatinib 9 mg QD
- description
- Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
- id
- OG001
- title
- Part 2: Intermittent Pemigatinib 13.5 mg QD
- description
- Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
- id
- OG002
- title
- Part 2: Continuous Pemigatinib 9 mg QD
- description
- Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
- id
- OG003
- title
- Part 2: Continuous Pemigatinib 13.5 mg QD
- description
- Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
- id
- OG004
- title
- Part 2: Continuous Pemigatinib 20 mg QD
- param Type
- NUMBER
- population Description
- Efficacy Evaluable Population: all enrolled participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- up to 126 days
- title
- Part 2: Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice