TriangleNCT01266967 · OUTCOME
Number of Response Genetics Incorporated (RGI) Investigational Use Only (IUO) Assay Mutation Positive Participants and THxID BRAF Assay Mutation Positive Participants With the Indicated Best Intracranial Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Screening
What was measured
The BRAF screening assay determines the specific BRAF mutational status (V600 E and K) in participants with metastatic melanoma who may benefit from treatment with GSK2118436. Per RECIST, version 1.1, CR is defined as the disappearance of all lesions. PR is defined as a \>=30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline (BL) sum of the diameters (e.g., percent change from BL). Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a \>=20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir \[smallest sum of diameters recorded since treatment start\]). In addition, the sum must have an absolute increase from nadir of 5 millimeters. Not evaluable: cannot be classified by a preceding definition.
Analysis population: V600EK and THIDEK Population: all enrolled participants who were V600E or V600K mutation positive by the RGI IUO assay
Groups in this outcome
RGI IUO Mutation Positive Participants
Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the RGI assay. The RGI assay is a BRAF mutation test developed by Response Genetics Incorporated, and was used to determine eligibility. It employs the allele-specific polymerase chain reaction (ASPCR) methodology, and was offered as an Investigational Use Only assay (only for pre-market investigational purposes).
ThxID BRAF Mutation Positive Participants
Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the ThxID assay. The RGI test was further validated by BioMerieux (BMX THxID assay) for regulatory approval. The THxID IUO assay was used to retrospectively confirm the RGI test results.
| Group | Source count |
|---|---|
| RGI IUO Mutation Positive Participants | 172 |
| ThxID BRAF Mutation Positive Participants | 155 |
Reported measurements
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RGI IUO Mutation Positive Participants | 2 | Not reported | Not reported | Not reported | Not reported |
| ThxID BRAF Mutation Positive Participants | 2 | Not reported | Not reported | Not reported | Not reported |
Partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RGI IUO Mutation Positive Participants | 52 | Not reported | Not reported | Not reported | Not reported |
| ThxID BRAF Mutation Positive Participants | 49 | Not reported | Not reported | Not reported | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RGI IUO Mutation Positive Participants | 78 | Not reported | Not reported | Not reported | Not reported |
| ThxID BRAF Mutation Positive Participants | 69 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RGI IUO Mutation Positive Participants | 26 | Not reported | Not reported | Not reported | Not reported |
| ThxID BRAF Mutation Positive Participants | 23 | Not reported | Not reported | Not reported | Not reported |
Not evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RGI IUO Mutation Positive Participants | 14 | Not reported | Not reported | Not reported | Not reported |
| ThxID BRAF Mutation Positive Participants | 12 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- Complete response
- categories
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 49
- title
- Partial response
- categories
- measurements
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 69
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 23
- title
- Progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- title
- Not evaluable
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 155
- units
- Participants
- description
- The BRAF screening assay determines the specific BRAF mutational status (V600 E and K) in participants with metastatic melanoma who may benefit from treatment with GSK2118436. Per RECIST, version 1.1, CR is defined as the disappearance of all lesions. PR is defined as a \>=30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline (BL) sum of the diameters (e.g., percent change from BL). Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a \>=20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir \[smallest sum of diameters recorded since treatment start\]). In addition, the sum must have an absolute increase from nadir of 5 millimeters. Not evaluable: cannot be classified by a preceding definition.
- groups
- description
- Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the RGI assay. The RGI assay is a BRAF mutation test developed by Response Genetics Incorporated, and was used to determine eligibility. It employs the allele-specific polymerase chain reaction (ASPCR) methodology, and was offered as an Investigational Use Only assay (only for pre-market investigational purposes).
- id
- OG000
- title
- RGI IUO Mutation Positive Participants
- description
- Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the ThxID assay. The RGI test was further validated by BioMerieux (BMX THxID assay) for regulatory approval. The THxID IUO assay was used to retrospectively confirm the RGI test results.
- id
- OG001
- title
- ThxID BRAF Mutation Positive Participants
- param Type
- NUMBER
- population Description
- V600EK and THIDEK Population: all enrolled participants who were V600E or V600K mutation positive by the RGI IUO assay
- reporting Status
- POSTED
- time Frame
- Screening
- title
- Number of Response Genetics Incorporated (RGI) Investigational Use Only (IUO) Assay Mutation Positive Participants and THxID BRAF Assay Mutation Positive Participants With the Indicated Best Intracranial Response
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice