TriangleNCT02124772 · OUTCOME
Objective Response Rate (ORR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the day of the first dose of any study drug up to the last dose, up to maximum duration of 63 months
What was measured
Objective response rate (ORR) was defined as the percentage of subjects with best overall response rate (BOR) with confirmation of complete response (CR) or partial response (PR) according to criteria for a specific disease type, among subjects with disease assessment at baseline. BOR for each subject was determined from the sequence of overall responses according to the rules for RECIST v1.1, RANO and Dombi criteria. ORR was calculated based on the investigator assessment of tumor response data and was based on confirmed responses.
Analysis population: All subjects who received at least one dose of trametinib in Part A and Part B or at least one dose of any component of the combination in Part C and Part D
Groups in this outcome
Part A - TMT 0.0125 mg/kg/Day
Participants treated with trametinib 0.0125 mg/kg/day
Part A - TMT 0.025 mg/kg/Day
Participants treated with trametinib 0.025 mg/kg/day
Part A - TMT 0.032 mg/kg/Day
Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
Part A - TMT 0.04 mg/kg/Day
Participants treated with trametinib 0.04 mg/kg/day
Part B - Neuroblastoma
Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
Part B - LGG Fusion
Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
Part B - NF-1 With PN
Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
Part B - BRAF V600 Mutant Solid Tumor
Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D
Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D
Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D
Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
Part D - LGG
Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
Part D - LCH
Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
| Group | Source count |
|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 3 |
| Part A - TMT 0.025 mg/kg/Day | 19 |
| Part A - TMT 0.032 mg/kg/Day | 12 |
| Part A - TMT 0.04 mg/kg/Day | 16 |
| Part B - Neuroblastoma | 11 |
| Part B - LGG Fusion | 10 |
| Part B - NF-1 With PN | 10 |
| Part B - BRAF V600 Mutant Solid Tumor | 10 |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 3 |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 9 |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 6 |
| Part D - LGG | 20 |
| Part D - LCH | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | 0.0 | 70.8 | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 5.3 | Not reported | 0.1 | 26.0 | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 8.3 | Not reported | 0.2 | 38.5 | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 0 | Not reported | 0.0 | 20.6 | Not reported |
| Part B - Neuroblastoma | 9.1 | Not reported | 0.2 | 41.3 | Not reported |
| Part B - LGG Fusion | 30.0 | Not reported | 6.7 | 65.2 | Not reported |
| Part B - NF-1 With PN | 0 | Not reported | 0.0 | 30.8 | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 50.0 | Not reported | 18.7 | 81.3 | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 66.7 | Not reported | 9.4 | 99.2 | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 33.3 | Not reported | 7.5 | 70.1 | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 66.7 | Not reported | 22.3 | 95.7 | Not reported |
| Part D - LGG | 55.0 | Not reported | 31.5 | 76.9 | Not reported |
| Part D - LCH | 60.0 | Not reported | 26.2 | 87.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 26.0
- value
- 5.3
- group Id
- OG002
- lower Limit
- 0.2
- upper Limit
- 38.5
- value
- 8.3
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 20.6
- value
- 0
- group Id
- OG004
- lower Limit
- 0.2
- upper Limit
- 41.3
- value
- 9.1
- group Id
- OG005
- lower Limit
- 6.7
- upper Limit
- 65.2
- value
- 30.0
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 30.8
- value
- 0
- group Id
- OG007
- lower Limit
- 18.7
- upper Limit
- 81.3
- value
- 50.0
- group Id
- OG008
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 66.7
- group Id
- OG009
- lower Limit
- 7.5
- upper Limit
- 70.1
- value
- 33.3
- group Id
- OG010
- lower Limit
- 22.3
- upper Limit
- 95.7
- value
- 66.7
- group Id
- OG011
- lower Limit
- 31.5
- upper Limit
- 76.9
- value
- 55.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 6
- group Id
- OG011
- value
- 20
- units
- Participants
- description
- Objective response rate (ORR) was defined as the percentage of subjects with best overall response rate (BOR) with confirmation of complete response (CR) or partial response (PR) according to criteria for a specific disease type, among subjects with disease assessment at baseline. BOR for each subject was determined from the sequence of overall responses according to the rules for RECIST v1.1, RANO and Dombi criteria. ORR was calculated based on the investigator assessment of tumor response data and was based on confirmed responses.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants treated with trametinib 0.0125 mg/kg/day
- id
- OG000
- title
- Part A - TMT 0.0125 mg/kg/Day
- description
- Participants treated with trametinib 0.025 mg/kg/day
- id
- OG001
- title
- Part A - TMT 0.025 mg/kg/Day
- description
- Participants under 6 years of age treated with trametinib 0.032 mg/kg/day
- id
- OG002
- title
- Part A - TMT 0.032 mg/kg/Day
- description
- Participants treated with trametinib 0.04 mg/kg/day
- id
- OG003
- title
- Part A - TMT 0.04 mg/kg/Day
- description
- Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
- id
- OG004
- title
- Part B - Neuroblastoma
- description
- Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day
- id
- OG005
- title
- Part B - LGG Fusion
- description
- Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day
- id
- OG006
- title
- Part B - NF-1 With PN
- description
- Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day
- id
- OG007
- title
- Part B - BRAF V600 Mutant Solid Tumor
- description
- Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)
- id
- OG008
- title
- Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D
- description
- Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
- id
- OG009
- title
- Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D
- description
- Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)
- id
- OG010
- title
- Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D
- description
- Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)
- id
- OG011
- title
- Part D - LGG
- param Type
- NUMBER
- population Description
- All subjects who received at least one dose of trametinib in Part A and Part B or at least one dose of any component of the combination in Part C and Part D
- reporting Status
- POSTED
- time Frame
- From the day of the first dose of any study drug up to the last dose, up to maximum duration of 63 months
- title
- Objective Response Rate (ORR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice