TriangleNCT03261947 · 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
- From date of randomization until disease progression or death, whichever occurs first (Up to approximately 34 months)
What was measured
PFS was defined as the time from the date of first dose to the date of first documentation of PD (including clinical progression or clinical deterioration) or death due to any cause, whichever occurs first. Per RECIST V1.1, PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Analysis population: Safety Analysis Set included all participants who received any amount of study drug.
Groups in this outcome
Western Safety Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
Pancreatic Cancer Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
Metastatic CRC Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
sqEC Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
sqNSCLC Cohort
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
| Group | Source count |
|---|---|
| Western Safety Cohort | 12 |
| Pancreatic Cancer Cohort | 15 |
| Metastatic CRC Cohort | 35 |
| sqEC Cohort | 21 |
| sqNSCLC Cohort | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Western Safety Cohort | 2.05 | Not reported | 1.31 | 5.09 | Not reported |
| Pancreatic Cancer Cohort | 1.31 | Not reported | 0.99 | 2.76 | Not reported |
| Metastatic CRC Cohort | 1.45 | Not reported | 1.35 | 2.56 | Not reported |
| sqEC Cohort | 3.02 | Not reported | 1.25 | 3.58 | Not reported |
| sqNSCLC Cohort | 2.12 | Not reported | 1.28 | 3.25 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.31
- upper Limit
- 5.09
- value
- 2.05
- group Id
- OG001
- lower Limit
- 0.99
- upper Limit
- 2.76
- value
- 1.31
- group Id
- OG002
- lower Limit
- 1.35
- upper Limit
- 2.56
- value
- 1.45
- group Id
- OG003
- lower Limit
- 1.25
- upper Limit
- 3.58
- value
- 3.02
- group Id
- OG004
- lower Limit
- 1.28
- upper Limit
- 3.25
- value
- 2.12
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 18
- units
- Participants
- description
- PFS was defined as the time from the date of first dose to the date of first documentation of PD (including clinical progression or clinical deterioration) or death due to any cause, whichever occurs first. Per RECIST V1.1, PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
- id
- OG000
- title
- Western Safety Cohort
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- id
- OG001
- title
- Pancreatic Cancer Cohort
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
- id
- OG002
- title
- Metastatic CRC Cohort
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- id
- OG003
- title
- sqEC Cohort
- description
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
- id
- OG004
- title
- sqNSCLC Cohort
- param Type
- MEDIAN
- population Description
- Safety Analysis Set included all participants who received any amount of study drug.
- reporting Status
- POSTED
- time Frame
- From date of randomization until disease progression or death, whichever occurs first (Up to approximately 34 months)
- 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