TriangleNCT02124772 · OUTCOME
Best Overall Response (BOR) 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- 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
Response evaluations were assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for subjects with solid tumors except neuroblastomas, primary central nervous system tumors (gliomas) or plexiform neurofibromas (PNs). Response evaluations for subjects with neuroblastomas could have included: measureable disease (by CT/MRI alone) assessed according to RECIST v1.1, evaluable disease assessed for meta-iodobenzylguanidine (MIBG) response, and biochemical (urine HVA/VMA) with bone marrow involvement assessed by Hematoxylin and Eosin staining of bilateral bone marrow biopsies and aspirates. Response evaluations for glioma subjects was assessed using Response Assessment in Neuro Oncology (RANO) criteria with solid tumors through MRI scans. Response evaluations of PNs were assessed using volumetric determination and Dombi criteria through MRI scans. The number of participants in each response category is reported in the table.
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
Complete response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
| Part D - LGG | 2 | Not reported | Not reported | Not reported | Not reported |
| Part D - LCH | 3 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 5 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 3 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
| Part D - LGG | 9 | Not reported | Not reported | Not reported | Not reported |
| Part D - LCH | 3 | Not reported | Not reported | Not reported | Not reported |
Stable disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 7 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 8 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 4 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 5 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
| Part D - LGG | 8 | Not reported | Not reported | Not reported | Not reported |
| Part D - LCH | 3 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 1 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part D - LGG | 0 | Not reported | Not reported | Not reported | Not reported |
| Part D - LCH | 0 | Not reported | Not reported | Not reported | Not reported |
Non-CR/Non-PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part D - LGG | 0 | Not reported | Not reported | Not reported | Not reported |
| Part D - LCH | 0 | Not reported | Not reported | Not reported | Not reported |
Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part D - LGG | 1 | Not reported | Not reported | Not reported | Not reported |
| Part D - LCH | 0 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - TMT 0.0125 mg/kg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.025 mg/kg/Day | 16 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.032 mg/kg/Day | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A - TMT 0.04 mg/kg/Day | 10 | Not reported | Not reported | Not reported | Not reported |
| Part B - Neuroblastoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B - LGG Fusion | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B - NF-1 With PN | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B - BRAF V600 Mutant Solid Tumor | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
| Part D - LGG | 0 | Not reported | Not reported | Not reported | Not reported |
| Part D - LCH | 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
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 2
- title
- Complete response (CR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 9
- title
- Partial response (PR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 8
- title
- Stable disease (SD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Progressive disease (PD)
- measurements
- 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
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Non-CR/Non-PD
- 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
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- Unknown
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- title
- Missing
- 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
- Response evaluations were assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for subjects with solid tumors except neuroblastomas, primary central nervous system tumors (gliomas) or plexiform neurofibromas (PNs). Response evaluations for subjects with neuroblastomas could have included: measureable disease (by CT/MRI alone) assessed according to RECIST v1.1, evaluable disease assessed for meta-iodobenzylguanidine (MIBG) response, and biochemical (urine HVA/VMA) with bone marrow involvement assessed by Hematoxylin and Eosin staining of bilateral bone marrow biopsies and aspirates. Response evaluations for glioma subjects was assessed using Response Assessment in Neuro Oncology (RANO) criteria with solid tumors through MRI scans. Response evaluations of PNs were assessed using volumetric determination and Dombi criteria through MRI scans. The number of participants in each response category is reported in the table.
- 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
- COUNT_OF_PARTICIPANTS
- 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
- Best Overall Response (BOR) Based on RECIST v1.1, RANO and Dombi Criteria and as Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice