TriangleNCT04322539 · OUTCOME
Correlation Between Fruquintinib Exposure (CminSS) and Efficacy Parameters (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- 1/(ng/mL)
- Interval / dispersion
- Not reported
- Time frame
- Up to 22 months
What was measured
Model-predicted steady-state minimum plasma concentrations (CminSS) of fruquintinib based on the starting dose or adjusted for relative dose intensity \[RDI\] were used as the exposure measures in the efficacy exposure-response analyses. The correlation between OS and exposure was estimated using multivariable Cox proportional hazards modeling. OS was analyzed as time-to-event variable using a survival model. The efficacy exposure-response analyses included participants with mCRC and pooled the data from the fruquintinib group of current Study 2019-013-GLOB1 (N=328) and from Cohort B of Study 2015-013-00US1 (NCT03251378) (N=40) as per planned analysis. Here, the "unit of measure" i.e., '1/(nanogram per milliliter \[ng/mL\])', corresponds to the coefficient that describes the relationship between the probability of survival and CminSS value.
Analysis population: The efficacy exposure-response analyses included participants who were evaluable for the population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for the parameter/endpoint in question. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. The population for this measure included participants from both studies 2015-013-00US1 and the current study.
Groups in this outcome
Fruquintinib: Pooled Studies for Exposure and Efficacy Analysis
Participants in the current 2019-013-GLOB1 (NCT04322539) study received 5 mg of fruquintinib oral capsules with BSC once daily for 3 weeks of continuous dosing, followed by a 1-week break during each 28-day treatment cycle. Participants in Cohort B of Study 2015-013-00US1 (NCT03251378) with metastatic colorectal carcinoma (mCRC) and treatment with chemotherapy and trifluridine, tipiracil, and/or regorafenib received fruquintinib 5 mg capsules, once daily, for 3 weeks on and 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by the Investigator, whichever occurred first.
| Group | Source count |
|---|---|
| Fruquintinib: Pooled Studies for Exposure and Efficacy Analysis | 368 |
Reported measurements
CminSS Coefficient Based on the Starting Dose for OS Exposure-Response Analyses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib: Pooled Studies for Exposure and Efficacy Analysis | 0.00193 | Not reported | Not reported | Not reported | Not reported |
CminSS Coefficient Based on the Adjusted RDI for OS Exposure-Response Analyses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib: Pooled Studies for Exposure and Efficacy Analysis | 0.000407 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- CminSS Based on the Starting Dose for OS Exposure-Response Analyses
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.0600
- statistical Method
- Wald test
- group Description
- CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.8065
- statistical Method
- Wald test
Complete source fields
- analyses
- group Description
- CminSS Based on the Starting Dose for OS Exposure-Response Analyses
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.0600
- statistical Method
- Wald test
- group Description
- CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.8065
- statistical Method
- Wald test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.00193
- title
- CminSS Coefficient Based on the Starting Dose for OS Exposure-Response Analyses
- categories
- measurements
- group Id
- OG000
- value
- 0.000407
- title
- CminSS Coefficient Based on the Adjusted RDI for OS Exposure-Response Analyses
- denoms
- counts
- group Id
- OG000
- value
- 368
- units
- Participants
- description
- Model-predicted steady-state minimum plasma concentrations (CminSS) of fruquintinib based on the starting dose or adjusted for relative dose intensity \[RDI\] were used as the exposure measures in the efficacy exposure-response analyses. The correlation between OS and exposure was estimated using multivariable Cox proportional hazards modeling. OS was analyzed as time-to-event variable using a survival model. The efficacy exposure-response analyses included participants with mCRC and pooled the data from the fruquintinib group of current Study 2019-013-GLOB1 (N=328) and from Cohort B of Study 2015-013-00US1 (NCT03251378) (N=40) as per planned analysis. Here, the "unit of measure" i.e., '1/(nanogram per milliliter \[ng/mL\])', corresponds to the coefficient that describes the relationship between the probability of survival and CminSS value.
- groups
- description
- Participants in the current 2019-013-GLOB1 (NCT04322539) study received 5 mg of fruquintinib oral capsules with BSC once daily for 3 weeks of continuous dosing, followed by a 1-week break during each 28-day treatment cycle. Participants in Cohort B of Study 2015-013-00US1 (NCT03251378) with metastatic colorectal carcinoma (mCRC) and treatment with chemotherapy and trifluridine, tipiracil, and/or regorafenib received fruquintinib 5 mg capsules, once daily, for 3 weeks on and 1 week off in each 28-day treatment cycle until disease progression, unacceptable toxicity, use of other antitumor treatment, withdrawal of consent, or discontinuation by the Investigator, whichever occurred first.
- id
- OG000
- title
- Fruquintinib: Pooled Studies for Exposure and Efficacy Analysis
- param Type
- NUMBER
- population Description
- The efficacy exposure-response analyses included participants who were evaluable for the population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for the parameter/endpoint in question. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. The population for this measure included participants from both studies 2015-013-00US1 and the current study.
- reporting Status
- POSTED
- time Frame
- Up to 22 months
- title
- Correlation Between Fruquintinib Exposure (CminSS) and Efficacy Parameters (OS)
- type
- SECONDARY
- unit Of Measure
- 1/(ng/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice