TriangleNCT04322539 · OUTCOME
Correlation Between Fruquintinib Exposure (CmaxSS) and Safety Parameters (Any Grade [Gr] and Grade 3+ (Gr3+): Dermatological Toxicity, Proteinuria and Gr Hemorrhage)
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 maximum plasma concentration (CmaxSS) of fruquintinib based on the assigned dose of fruquintinib were investigated as fruquintinib exposure measure for the safety exposure-response analyses. The correlation between exposure and the probability of experiencing these AEs was evaluated using logistic regression analysis, with the slope serving as the estimate. The safety exposure-response analysis included participants with cancer, and the data of this outcome measure were pooled with data from the following studies as per the planned analysis: 2019-013-GLOB1 (NCT04322539) (N=334), 2009-013-00CH1 (NCT01645215) (N=40), 2012-013-00CH3 (NCT01975077) (N=40), and 2015-013-00US1 (NCT03251378) (N=101). Here, the "unit of measure" i.e., '1/(ng/mL)', corresponds to the coefficient that describes the relationship between the probability of occurrence of the safety parameter and CmaxSS value.
Analysis population: Safety exposure-response analyses included participants who were evaluable for population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for 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 2019-013-GLOB1, 2009-013-00CH1, 2012-013-00CH3, and 2015-013-00US1.
Groups in this outcome
Fruquintinib: Pooled Studies for Exposure and Safety Analysis
Participants in the current 2019-013-GLOB1 (NCT04322539) study received 5 mg of fruquintinib oral capsules once daily for 3 weeks of continuous dosing, followed by a 1-week break during each 28-day treatment cycle. Participants in the 2009-013-00CH1 (NCT01645215) study received 1 mg to 6 mg of fruquintinib oral capsule once daily and 5 mg to 6 mg of fruquintinib oral capsule for 3 weeks on and 1 week off during each 28-day treatment cycle. Participants in the 2012-013-00CH3 (NCT01975077) study received 4 mg of fruquintinib capsule once daily in 28-day cycles. Participants in the Study 2015-013-00US1 (NCT03251378) with advanced solid tumors of any type or with mCRC received fruquintinib 3 mg or 5 mg 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 Safety Analysis | 515 |
Reported measurements
CmaxSS Coefficient for Gr Dermatological toxicity for Exposure-Response Analyses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib: Pooled Studies for Exposure and Safety Analysis | 0.00134 | Not reported | Not reported | Not reported | Not reported |
CmaxSS Coefficient for Gr3+ Dermatological Toxicity for Exposure-Response Analyses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib: Pooled Studies for Exposure and Safety Analysis | 0.00411 | Not reported | Not reported | Not reported | Not reported |
CmaxSS Coefficient for Gr Proteinuria for Exposure-Response Analyses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib: Pooled Studies for Exposure and Safety Analysis | -0.00101 | Not reported | Not reported | Not reported | Not reported |
CmaxSS Coefficient for Gr3+ Proteinuria for Exposure-Response Analyses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib: Pooled Studies for Exposure and Safety Analysis | 0.00143 | Not reported | Not reported | Not reported | Not reported |
CmaxSS Coefficient for Gr Hemorrhage for Exposure-Response Analyses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fruquintinib: Pooled Studies for Exposure and Safety Analysis | 0.00180 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.265
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.0159
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr Proteinuria for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.484
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.642
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.166
- statistical Method
- Wald test
Complete source fields
- analyses
- group Description
- CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.265
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.0159
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr Proteinuria for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.484
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.642
- statistical Method
- Wald test
- group Description
- CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.166
- statistical Method
- Wald test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.00134
- title
- CmaxSS Coefficient for Gr Dermatological toxicity for Exposure-Response Analyses
- categories
- measurements
- group Id
- OG000
- value
- 0.00411
- title
- CmaxSS Coefficient for Gr3+ Dermatological Toxicity for Exposure-Response Analyses
- categories
- measurements
- group Id
- OG000
- value
- -0.00101
- title
- CmaxSS Coefficient for Gr Proteinuria for Exposure-Response Analyses
- categories
- measurements
- group Id
- OG000
- value
- 0.00143
- title
- CmaxSS Coefficient for Gr3+ Proteinuria for Exposure-Response Analyses
- categories
- measurements
- group Id
- OG000
- value
- 0.00180
- title
- CmaxSS Coefficient for Gr Hemorrhage for Exposure-Response Analyses
- denoms
- counts
- group Id
- OG000
- value
- 515
- units
- Participants
- description
- Model-predicted steady-state maximum plasma concentration (CmaxSS) of fruquintinib based on the assigned dose of fruquintinib were investigated as fruquintinib exposure measure for the safety exposure-response analyses. The correlation between exposure and the probability of experiencing these AEs was evaluated using logistic regression analysis, with the slope serving as the estimate. The safety exposure-response analysis included participants with cancer, and the data of this outcome measure were pooled with data from the following studies as per the planned analysis: 2019-013-GLOB1 (NCT04322539) (N=334), 2009-013-00CH1 (NCT01645215) (N=40), 2012-013-00CH3 (NCT01975077) (N=40), and 2015-013-00US1 (NCT03251378) (N=101). Here, the "unit of measure" i.e., '1/(ng/mL)', corresponds to the coefficient that describes the relationship between the probability of occurrence of the safety parameter and CmaxSS value.
- groups
- description
- Participants in the current 2019-013-GLOB1 (NCT04322539) study received 5 mg of fruquintinib oral capsules once daily for 3 weeks of continuous dosing, followed by a 1-week break during each 28-day treatment cycle. Participants in the 2009-013-00CH1 (NCT01645215) study received 1 mg to 6 mg of fruquintinib oral capsule once daily and 5 mg to 6 mg of fruquintinib oral capsule for 3 weeks on and 1 week off during each 28-day treatment cycle. Participants in the 2012-013-00CH3 (NCT01975077) study received 4 mg of fruquintinib capsule once daily in 28-day cycles. Participants in the Study 2015-013-00US1 (NCT03251378) with advanced solid tumors of any type or with mCRC received fruquintinib 3 mg or 5 mg 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 Safety Analysis
- param Type
- NUMBER
- population Description
- Safety exposure-response analyses included participants who were evaluable for population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for 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 2019-013-GLOB1, 2009-013-00CH1, 2012-013-00CH3, and 2015-013-00US1.
- reporting Status
- POSTED
- time Frame
- Up to 22 months
- title
- Correlation Between Fruquintinib Exposure (CmaxSS) and Safety Parameters (Any Grade [Gr] and Grade 3+ (Gr3+): Dermatological Toxicity, Proteinuria and Gr Hemorrhage)
- type
- SECONDARY
- unit Of Measure
- 1/(ng/mL)
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Preserved source evidence · Independent clinical review pending · Not medical advice