TriangleNCT02864992 · OUTCOME
Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
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
- Time from first treatment up to data cutoff (approximately Month 66)
What was measured
Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Analysis population: Safty Analysis Set included all participants in Cohort A who were administered at least 1 dose of tepotinib, including participants with METex14 skipping alterations not confirmed by a validated central laboratory assay.
Groups in this outcome
Part 1: Cohort A: METex14 Skipping Alterations
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
| Group | Source count |
|---|---|
| Part 1: Cohort A: METex14 Skipping Alterations | 152 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cohort A: METex14 Skipping Alterations | 46.7 | Not reported | 38.6 | 55.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.6
- upper Limit
- 55.0
- value
- 46.7
- denoms
- counts
- group Id
- OG000
- value
- 152
- units
- Participants
- description
- Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
- id
- OG000
- title
- Part 1: Cohort A: METex14 Skipping Alterations
- param Type
- NUMBER
- population Description
- Safty Analysis Set included all participants in Cohort A who were administered at least 1 dose of tepotinib, including participants with METex14 skipping alterations not confirmed by a validated central laboratory assay.
- reporting Status
- POSTED
- time Frame
- Time from first treatment up to data cutoff (approximately Month 66)
- title
- Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice