NCT04844073 · OUTCOME
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-186
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)
What was measured
AUCinf of TAK-186 was not analysed.
Analysis population: AUCinf was considered a supplementary analysis, as it was essentially equivalent to AUCtau given the half-life of TAK-186. Therefore, no participants were evaluated for this outcome measure.
Groups in this outcome
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone
Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
Participants in Dose Escalation Phase and Cohort Expansion Phase received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
| Group | Source count |
|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 0 |
| Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone | 0 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- units
- Participants
- description
- AUCinf of TAK-186 was not analysed.
- groups
- description
- Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
- id
- OG000
- title
- Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
- description
- Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
- id
- OG001
- title
- Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
- id
- OG002
- title
- Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
- id
- OG003
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
- description
- Participants in Dose Escalation Phase and Cohort Expansion Phase received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
- id
- OG004
- title
- Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
- id
- OG005
- title
- Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone
- description
- Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
- id
- OG006
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
- population Description
- AUCinf was considered a supplementary analysis, as it was essentially equivalent to AUCtau given the half-life of TAK-186. Therefore, no participants were evaluated for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)
- title
- AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-186
- type
- OTHER_PRE_SPECIFIED
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Preserved source evidence · Not medical advice
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