TriangleNCT01524978 · OUTCOME
Confirmed Best Overall Response Rate (BORR)
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
- Up to approximately 3 years
What was measured
Confirmed BORR: percentage of participants with an objective response (OR) (complete response \[CR\], partial response \[PR\], stringent CR \[sCR\] or very good PR \[VGPR\]) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \<200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal free light chain (FLC) ratio and no clonal cells in bone marrow.
Analysis population: ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not.
Groups in this outcome
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
Participants with NSCLC were treated with vemurafenib monotherapy.
Cohort 2: Ovarian Cancer - Vemurafenib
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Cohort 3a: Colorectal Cancer - Vemurafenib
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Cohort 4: Cholangiocarcinoma - Vemurafenib
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Cohort 6: Multiple Myeloma - Vemurafenib
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Cohort 7a: ECD/LCH - Vemurafenib
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Cohort 7d: Early Stage Astrocytoma - Vemurafenib
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
| Group | Source count |
|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | 62 |
| Cohort 2: Ovarian Cancer - Vemurafenib | 4 |
| Cohort 3a: Colorectal Cancer - Vemurafenib | 10 |
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 27 |
| Cohort 4: Cholangiocarcinoma - Vemurafenib | 9 |
| Cohort 6: Multiple Myeloma - Vemurafenib | 9 |
| Cohort 7a: ECD/LCH - Vemurafenib | 26 |
| Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | 12 |
| Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | 12 |
| Cohort 7d: Early Stage Astrocytoma - Vemurafenib | 9 |
| Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib | 37.1 | Not reported | 25.16 | 50.31 | Not reported |
| Cohort 2: Ovarian Cancer - Vemurafenib | 50.0 | Not reported | 6.76 | 93.24 | Not reported |
| Cohort 3a: Colorectal Cancer - Vemurafenib | 0 | Not reported | 0.00 | 30.85 | Not reported |
| Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab | 7.4 | Not reported | 0.91 | 24.29 | Not reported |
| Cohort 4: Cholangiocarcinoma - Vemurafenib | 22.2 | Not reported | 2.81 | 60.01 | Not reported |
| Cohort 6: Multiple Myeloma - Vemurafenib | 22.2 | Not reported | 2.81 | 60.01 | Not reported |
| Cohort 7a: ECD/LCH - Vemurafenib | 61.5 | Not reported | 40.57 | 79.77 | Not reported |
| Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib | 25.0 | Not reported | 5.49 | 57.19 | Not reported |
| Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib | 16.7 | Not reported | 2.09 | 48.41 | Not reported |
| Cohort 7d: Early Stage Astrocytoma - Vemurafenib | 33.3 | Not reported | 7.49 | 70.07 | Not reported |
| Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib | 17.9 | Not reported | 6.06 | 36.89 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.16
- upper Limit
- 50.31
- value
- 37.1
- group Id
- OG001
- lower Limit
- 6.76
- upper Limit
- 93.24
- value
- 50.0
- group Id
- OG002
- lower Limit
- 0.00
- upper Limit
- 30.85
- value
- 0
- group Id
- OG003
- lower Limit
- 0.91
- upper Limit
- 24.29
- value
- 7.4
- group Id
- OG004
- lower Limit
- 2.81
- upper Limit
- 60.01
- value
- 22.2
- group Id
- OG005
- lower Limit
- 2.81
- upper Limit
- 60.01
- value
- 22.2
- group Id
- OG006
- lower Limit
- 40.57
- upper Limit
- 79.77
- value
- 61.5
- group Id
- OG007
- lower Limit
- 5.49
- upper Limit
- 57.19
- value
- 25.0
- group Id
- OG008
- lower Limit
- 2.09
- upper Limit
- 48.41
- value
- 16.7
- group Id
- OG009
- lower Limit
- 7.49
- upper Limit
- 70.07
- value
- 33.3
- group Id
- OG010
- lower Limit
- 6.06
- upper Limit
- 36.89
- value
- 17.9
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 26
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 12
- group Id
- OG009
- value
- 9
- group Id
- OG010
- value
- 28
- units
- Participants
- description
- Confirmed BORR: percentage of participants with an objective response (OR) (complete response \[CR\], partial response \[PR\], stringent CR \[sCR\] or very good PR \[VGPR\]) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \<200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal free light chain (FLC) ratio and no clonal cells in bone marrow.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with NSCLC were treated with vemurafenib monotherapy.
- id
- OG000
- title
- Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
- description
- Participants with ovarian cancer were treated with vemurafenib monotherapy.
- id
- OG001
- title
- Cohort 2: Ovarian Cancer - Vemurafenib
- description
- Participants with colorectal cancer were treated with vemurafenib monotherapy.
- id
- OG002
- title
- Cohort 3a: Colorectal Cancer - Vemurafenib
- description
- Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
- id
- OG003
- title
- Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
- description
- Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
- id
- OG004
- title
- Cohort 4: Cholangiocarcinoma - Vemurafenib
- description
- Participants with multiple myeloma were treated with vemurafenib monotherapy.
- id
- OG005
- title
- Cohort 6: Multiple Myeloma - Vemurafenib
- description
- Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
- id
- OG006
- title
- Cohort 7a: ECD/LCH - Vemurafenib
- description
- Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
- id
- OG007
- title
- Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
- description
- Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
- id
- OG008
- title
- Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
- description
- Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
- id
- OG009
- title
- Cohort 7d: Early Stage Astrocytoma - Vemurafenib
- description
- Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
- id
- OG010
- title
- Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
- param Type
- NUMBER
- population Description
- ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not.
- reporting Status
- POSTED
- time Frame
- Up to approximately 3 years
- title
- Confirmed Best Overall Response Rate (BORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice