TriangleNCT01245062 · OUTCOME
Number of Participants With OR as Assessed by the Investigator and Independent Review
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
- Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
What was measured
OR is defined as the number of participants with evidence of complete response (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.
Analysis population: ITT Population
Groups in this outcome
Trametinib
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
Chemotherapy
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
| Group | Source count |
|---|---|
| Trametinib | 214 |
| Chemotherapy | 108 |
Reported measurements
Investigator-Assessed: CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 8 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
Investigator-Assessed: PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 53 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 8 | Not reported | Not reported | Not reported | Not reported |
Independent Review: CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
Independent Review: PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 41 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 2
- title
- Investigator-Assessed: CR
- categories
- measurements
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 8
- title
- Investigator-Assessed: PR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Independent Review: CR
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 4
- title
- Independent Review: PR
- denoms
- counts
- group Id
- OG000
- value
- 214
- group Id
- OG001
- value
- 108
- units
- Participants
- description
- OR is defined as the number of participants with evidence of complete response (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.
- groups
- description
- Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
- id
- OG000
- title
- Trametinib
- description
- Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
- id
- OG001
- title
- Chemotherapy
- param Type
- NUMBER
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
- title
- Number of Participants With OR as Assessed by the Investigator and Independent Review
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice