TriangleNCT02142803 · OUTCOME
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
- Up to 2 years
What was measured
Progression is defined as follows: 1. Non-GBM Solid Tumors (Endometrial \& Ovarian Cancers) - using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline (v.1.1): * Target Lesions: \>/= 20% increase in the sum of the longest diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. * Non-Target Lesions: The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. 2. GBM - Using the Response Assessment in Neuro-Oncology (RANO) criteria, any of the criteria below qualify for progression: * \>/= 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable/increasing dose of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable/increasing dose of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other cause
Analysis population: * Given the limited sample sizes for Dose Levels 1 \& 2 (3 patients each), the #s presented here may not be statistically valid. * Censoring \& Final PFS #s: 9 patients treated @ Dose Level 3 were censored from PFS analysis for initiation of new therapy or withdrawal of consent. 2 additional patients treated at Dose Level 3 were censored from PFS analysis because they never had a useable scan on study.
Groups in this outcome
Dose Level 1
3 mg/day MLN0128
Dose Level 2
4 mg/day MLN0128
Dose Level 3 (MTD)
5 mg/day MLN0128
| Group | Source count |
|---|---|
| Dose Level 1 | 3 |
| Dose Level 2 | 3 |
| Dose Level 3 (MTD) | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 1.6 | Not reported | 1.0 | NA | Sample size of 3 patients is too low. |
| Dose Level 2 | 7.3 | Not reported | 2.1 | NA | Sample size of 3 patients is too low. |
| Dose Level 3 (MTD) | 5.4 | Not reported | 2.8 | 7.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Sample size of 3 patients is too low.
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 1.6
- comment
- Sample size of 3 patients is too low.
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- NA
- value
- 7.3
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- 7.4
- value
- 5.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 33
- units
- Participants
- description
- Progression is defined as follows: 1. Non-GBM Solid Tumors (Endometrial \& Ovarian Cancers) - using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline (v.1.1): * Target Lesions: \>/= 20% increase in the sum of the longest diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. * Non-Target Lesions: The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. 2. GBM - Using the Response Assessment in Neuro-Oncology (RANO) criteria, any of the criteria below qualify for progression: * \>/= 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable/increasing dose of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable/increasing dose of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other cause
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 3 mg/day MLN0128
- id
- OG000
- title
- Dose Level 1
- description
- 4 mg/day MLN0128
- id
- OG001
- title
- Dose Level 2
- description
- 5 mg/day MLN0128
- id
- OG002
- title
- Dose Level 3 (MTD)
- param Type
- MEDIAN
- population Description
- * Given the limited sample sizes for Dose Levels 1 \& 2 (3 patients each), the #s presented here may not be statistically valid. * Censoring \& Final PFS #s: 9 patients treated @ Dose Level 3 were censored from PFS analysis for initiation of new therapy or withdrawal of consent. 2 additional patients treated at Dose Level 3 were censored from PFS analysis because they never had a useable scan on study.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice