TriangleNCT03261947 · OUTCOME
t1/2z: Terminal Disposition Phase Half-life for TAK-931
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Analysis population: PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.
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.
| Group | Source count |
|---|---|
| Western Safety Cohort | 11 |
| Pancreatic Cancer Cohort | 10 |
| Metastatic CRC Cohort | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Western Safety Cohort | 5.95 | Not reported | 4.3 | 6.7 | Not reported |
| Pancreatic Cancer Cohort | 5.53 | Not reported | 3.7 | 8.0 | Not reported |
| Metastatic CRC Cohort | 6.18 | Not reported | 4.8 | 8.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.3
- upper Limit
- 6.7
- value
- 5.95
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 8.0
- value
- 5.53
- group Id
- OG002
- lower Limit
- 4.8
- upper Limit
- 8.4
- value
- 6.18
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 11
- units
- Participants
- dispersion Type
- Full Range
- 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
- param Type
- MEDIAN
- population Description
- PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
- title
- t1/2z: Terminal Disposition Phase Half-life for TAK-931
- type
- SECONDARY
- unit Of Measure
- hour
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice