TriangleNCT04844073 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From start of study drug up to end of study (up to 22 months)
What was measured
PFS was measured from the date of first dose to first occurrence of objective PD using both RECIST v1.1, or the date of death from any cause. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: Safety population included all participants who received at least 1 dose of TAK-186.
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.
Cohort Expansion Phase: NSCLC
Participants with NSCLC 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.
| 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 | 5 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 10 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 17 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 13 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 5 |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 4 |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 8 |
| Cohort Expansion Phase: NSCLC | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone | 6.0 | Not reported | NA | NA | The 90% confidence interval was not estimable due to single participant. |
| Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone | 6.0 | Not reported | NA | NA | The 90% confidence interval was not estimable due to single participant. |
| Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone | 10.2 | Not reported | 6.9 | NA | The upper limit of 90% confidence interval was not estimable due to an insufficient number of participants with events. |
| Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone | 9.3 | Not reported | 6.9 | 14.9 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone | 15.1 | Not reported | 6.4 | 31.6 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone | 6.9 | Not reported | 5.6 | 13.0 | Not reported |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone | 6.6 | Not reported | 1.9 | NA | The upper limit of 90% confidence interval was not estimable due to an insufficient number of participants with events. |
| Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone | 11.7 | Not reported | 2.9 | NA | The upper limit of 90% confidence interval was not estimable due to an insufficient number of participants with events. |
| Dose Escalation Phase:TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone | 7.0 | Not reported | 5.9 | 12.0 | Not reported |
| Cohort Expansion Phase: NSCLC | 7.9 | Not reported | 5.9 | 8.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The 90% confidence interval was not estimable due to single participant.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.0
- comment
- The 90% confidence interval was not estimable due to single participant.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.0
- comment
- The upper limit of 90% confidence interval was not estimable due to an insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 6.9
- upper Limit
- NA
- value
- 10.2
- group Id
- OG003
- lower Limit
- 6.9
- upper Limit
- 14.9
- value
- 9.3
- group Id
- OG004
- lower Limit
- 6.4
- upper Limit
- 31.6
- value
- 15.1
- group Id
- OG005
- lower Limit
- 5.6
- upper Limit
- 13.0
- value
- 6.9
- comment
- The upper limit of 90% confidence interval was not estimable due to an insufficient number of participants with events.
- group Id
- OG006
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 6.6
- comment
- The upper limit of 90% confidence interval was not estimable due to an insufficient number of participants with events.
- group Id
- OG007
- lower Limit
- 2.9
- upper Limit
- NA
- value
- 11.7
- group Id
- OG008
- lower Limit
- 5.9
- upper Limit
- 12.0
- value
- 7.0
- group Id
- OG009
- lower Limit
- 5.9
- upper Limit
- 8.1
- value
- 7.9
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 31
- units
- Participants
- description
- PFS was measured from the date of first dose to first occurrence of objective PD using both RECIST v1.1, or the date of death from any cause. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- dispersion Type
- 90% Confidence Interval
- 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
- description
- Participants with NSCLC 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
- OG009
- title
- Cohort Expansion Phase: NSCLC
- param Type
- MEDIAN
- population Description
- Safety population included all participants who received at least 1 dose of TAK-186.
- reporting Status
- POSTED
- time Frame
- From start of study drug up to end of study (up to 22 months)
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice