TriangleNCT02988817 · OUTCOME
AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) 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*pg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
What was measured
The AUC0-inf of MMAE 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: The 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 | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 3832.48 | 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 | 6144.11 | 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 | 13673.7 | 110.4 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 26549.1 | 82.9 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 33494.5 | 47.1 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 50459.6 | 117.0 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 48626.4 | 95.5 | 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 | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 3248.46 | 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 | 7452.05 | 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 | 4338.20 | 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 | 47093.9 | 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 | 30512.0 | 47.8 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 34188.6 | 46.6 | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 16754.5 | NA | Not reported | Not reported | Geometric coefficient of variation was not derived as only one participant was evaluated for this arm. |
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
- 3832.48
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG001
- spread
- NA
- value
- 6144.11
- group Id
- OG002
- spread
- 110.4
- value
- 13673.7
- group Id
- OG003
- spread
- 82.9
- value
- 26549.1
- group Id
- OG004
- spread
- 47.1
- value
- 33494.5
- group Id
- OG005
- spread
- 117.0
- value
- 50459.6
- group Id
- OG006
- spread
- 95.5
- value
- 48626.4
- 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
- 2
- 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
- 3248.46
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG001
- spread
- NA
- value
- 7452.05
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG002
- spread
- NA
- value
- 4338.20
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG003
- spread
- NA
- value
- 47093.9
- group Id
- OG004
- spread
- 47.8
- value
- 30512.0
- group Id
- OG005
- spread
- 46.6
- value
- 34188.6
- comment
- Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
- group Id
- OG006
- spread
- NA
- value
- 16754.5
- 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
- 1
- 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 MMAE 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
- The 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, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
- title
- AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part
- type
- SECONDARY
- unit Of Measure
- day*pg/mL
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Preserved source evidence · Not medical advice