TriangleNCT03261947 · OUTCOME
Overall Survival (OS) in the Tumor-Specific Cohorts
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 approximately 43 months
What was measured
OS was defined as the time from the date of first dose of study drug to death due to any cause.
Analysis population: Safety Analysis Set included all participants who received any amount of study drug. Participants without documentation of death at the time of analysis were censored at the date last known to be alive. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.
Groups in this outcome
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 |
|---|---|
| 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 |
|---|---|---|---|---|---|
| Pancreatic Cancer Cohort | 4.67 | Not reported | 1.77 | 7.06 | Not reported |
| Metastatic CRC Cohort | 7.72 | Not reported | 5.68 | 11.96 | Not reported |
| sqEC Cohort | 8.61 | Not reported | 3.94 | 42.71 | Not reported |
| sqNSCLC Cohort | NA | Not reported | NA | NA | The median, upper and lower limits of 95% confidence interval were not evaluable due to fewer number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.77
- upper Limit
- 7.06
- value
- 4.67
- group Id
- OG001
- lower Limit
- 5.68
- upper Limit
- 11.96
- value
- 7.72
- group Id
- OG002
- lower Limit
- 3.94
- upper Limit
- 42.71
- value
- 8.61
- comment
- The median, upper and lower limits of 95% confidence interval were not evaluable due to fewer number of participants with events.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 18
- units
- Participants
- description
- OS was defined as the time from the date of first dose of study drug to death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- title
- sqNSCLC Cohort
- param Type
- MEDIAN
- population Description
- Safety Analysis Set included all participants who received any amount of study drug. Participants without documentation of death at the time of analysis were censored at the date last known to be alive. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.
- reporting Status
- POSTED
- time Frame
- Up to approximately 43 months
- title
- Overall Survival (OS) in the Tumor-Specific Cohorts
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice