TriangleNCT01871727 · OUTCOME
Lead-In Part: Volume of Distribution at Steady State (Vdss) of E7777
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- milliliter per kilogram (mL/kg)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
What was measured
Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles.
Analysis population: Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints.
Groups in this outcome
Lead-In Part: E7777 6 mcg/kg
Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 9 mcg/kg
Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
Lead-In Part: E7777 12 mcg/kg
Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 15 mcg/kg
Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
| Group | Source count |
|---|---|
| Lead-In Part: E7777 6 mcg/kg | 2 |
| Lead-In Part: E7777 9 mcg/kg | 4 |
| Lead-In Part: E7777 12 mcg/kg | 5 |
| Lead-In Part: E7777 15 mcg/kg | 1 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Lead-In Part: E7777 6 mcg/kg | 2 |
| Lead-In Part: E7777 9 mcg/kg | 4 |
| Lead-In Part: E7777 12 mcg/kg | 5 |
| Lead-In Part: E7777 15 mcg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 39.8 | 4.81 | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 60.3 | 19.50 | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 61 | 21.80 | Not reported | Not reported | Not reported |
| Lead-In Part: E7777 15 mcg/kg | 37 | NA | Not reported | Not reported | Standard deviation could not be estimated as insufficient number of participants were available for analysis. |
Cycle 3 Day 1
| Group | Source count |
|---|---|
| Lead-In Part: E7777 6 mcg/kg | 1 |
| Lead-In Part: E7777 9 mcg/kg | 0 |
| Lead-In Part: E7777 12 mcg/kg | 0 |
| Lead-In Part: E7777 15 mcg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 69.1 | NA | Not reported | Not reported | Standard deviation could not be estimated as insufficient number of participants were available for analysis. |
Cycle 5 Day 1
| Group | Source count |
|---|---|
| Lead-In Part: E7777 6 mcg/kg | 0 |
| Lead-In Part: E7777 9 mcg/kg | 0 |
| Lead-In Part: E7777 12 mcg/kg | 1 |
| Lead-In Part: E7777 15 mcg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 12 mcg/kg | 53.3 | NA | Not reported | Not reported | Standard deviation could not be estimated as insufficient number of participants were available for analysis. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.81
- value
- 39.8
- group Id
- OG001
- spread
- 19.50
- value
- 60.3
- group Id
- OG002
- spread
- 21.80
- value
- 61
- comment
- Standard deviation could not be estimated as insufficient number of participants were available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 37
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- comment
- Standard deviation could not be estimated as insufficient number of participants were available for analysis.
- group Id
- OG000
- spread
- NA
- value
- 69.1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 3 Day 1
- categories
- measurements
- comment
- Standard deviation could not be estimated as insufficient number of participants were available for analysis.
- group Id
- OG002
- spread
- NA
- value
- 53.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 5 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Participants were not available for analysis in 15 mcg/kg (Cycles 3 and 5), 6 mcg/kg (Cycle 5), 9 mcg/kg (Cycles 3 and 5), 12 mcg/kg (Cycle 3), hence no PK data was collected and analyzed for these doses and cycles.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG000
- title
- Lead-In Part: E7777 6 mcg/kg
- description
- Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
- id
- OG001
- title
- Lead-In Part: E7777 9 mcg/kg
- description
- Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG002
- title
- Lead-In Part: E7777 12 mcg/kg
- description
- Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG003
- title
- Lead-In Part: E7777 15 mcg/kg
- param Type
- MEAN
- population Description
- Lead-in PK analysis set included all participants who received at least one dose of study drug and from whom at least one valid E7777 PK parameter was obtained. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given timepoints.
- reporting Status
- POSTED
- time Frame
- Cycles 1, 3, 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
- title
- Lead-In Part: Volume of Distribution at Steady State (Vdss) of E7777
- type
- SECONDARY
- unit Of Measure
- milliliter per kilogram (mL/kg)
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Preserved source evidence · Not medical advice