TriangleNCT02988817 · OUTCOME
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- day*ug/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
What was measured
The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Analysis population: Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Groups in this outcome
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 11 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 3 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 6.143 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 13.233 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 18.353 | 8.6 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 40.921 | 27.7 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 64.140 | 13.2 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 67.998 | 32.2 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 76.264 | 31.7 | Not reported | Not reported | Not reported |
Cycle 3 Day 1
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 8 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 4 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 5.780 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 10.892 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 18.664 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 39.589 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 56.842 | 23.8 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 61.161 | 10.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG000
- spread
- NA
- value
- 6.143
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG001
- spread
- NA
- value
- 13.233
- group Id
- OG002
- spread
- 8.6
- value
- 18.353
- group Id
- OG003
- spread
- 27.7
- value
- 40.921
- group Id
- OG004
- spread
- 13.2
- value
- 64.140
- group Id
- OG005
- spread
- 32.2
- value
- 67.998
- group Id
- OG006
- spread
- 31.7
- value
- 76.264
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG000
- spread
- NA
- value
- 5.780
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG001
- spread
- NA
- value
- 10.892
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG002
- spread
- NA
- value
- 18.664
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG003
- spread
- NA
- value
- 39.589
- group Id
- OG004
- spread
- 23.8
- value
- 56.842
- group Id
- OG005
- spread
- 10.7
- value
- 61.161
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- Cycle 3 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 3
- units
- Participants
- description
- The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
- id
- OG000
- title
- Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
- id
- OG001
- title
- Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
- id
- OG002
- title
- Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
- id
- OG003
- title
- Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
- id
- OG004
- title
- Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG005
- title
- Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
- id
- OG006
- title
- Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
- reporting Status
- POSTED
- time Frame
- Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
- title
- Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
- type
- SECONDARY
- unit Of Measure
- day*ug/mL
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Preserved source evidence · Not medical advice