TriangleNCT04844073 · OUTCOME
Dose Escalation Phase: Number of Participants With a DLTs
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From start of study drug up to Cycle 1 Day 28
What was measured
DLTs were evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0. DLT criteria were defined as any of the following events: Hematologic DLTs - Grade 4 neutropenia lasting greater than (\>) 5 days; Grade \>=3 febrile neutropenia lasting \>48 hours or Grade \>=3 febrile neutropenia associated with hemodynamic instability or infection; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia and clinically significant bleeding; Grade \>=3 hemolysis. Hepatic DLTs - Grade 3 ALT or AST increase; Grade 3 bilirubin increase. Nonhematologic DLTs are Grade \>=3 nonhematologic AEs.
Analysis population: DLT-evaluable population included all participants who received at least 3 doses of TAK-186 in dose cohort, or at least 2 target doses of TAK-186, or experienced a DLT within the DLT-evaluation period.
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: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
Participants 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. Dose E is higher than Dose C and B.
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone
Participants 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 was administered pre-infusion. Dose D is higher than Dose B and C.
Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double 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 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 | 1 |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 1 |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 3 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 8 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 14 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 11 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 4 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 2 |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 7
- units
- Participants
- description
- DLTs were evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0. DLT criteria were defined as any of the following events: Hematologic DLTs - Grade 4 neutropenia lasting greater than (\>) 5 days; Grade \>=3 febrile neutropenia lasting \>48 hours or Grade \>=3 febrile neutropenia associated with hemodynamic instability or infection; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia and clinically significant bleeding; Grade \>=3 hemolysis. Hepatic DLTs - Grade 3 ALT or AST increase; Grade 3 bilirubin increase. Nonhematologic DLTs are Grade \>=3 nonhematologic AEs.
- 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 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. Dose E is higher than Dose C and B.
- id
- OG004
- title
- Dose Escalation 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 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
- OG005
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double 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
- OG006
- 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 was administered pre-infusion. Dose D is higher than Dose B and C.
- id
- OG007
- title
- Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + 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 was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
- id
- OG008
- title
- Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- DLT-evaluable population included all participants who received at least 3 doses of TAK-186 in dose cohort, or at least 2 target doses of TAK-186, or experienced a DLT within the DLT-evaluation period.
- reporting Status
- POSTED
- time Frame
- From start of study drug up to Cycle 1 Day 28
- title
- Dose Escalation Phase: Number of Participants With a DLTs
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice