TriangleNCT01327053 · OUTCOME
Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS)
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
- 6 months
What was measured
ORR is the percentage of patient's objective response (ORR) by 6 months after starting LDE225 treatment. A responder was defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm.
Analysis population: The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).
Groups in this outcome
LDE225 200mg laBCC
The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225 800mg laBCC
The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225 200mg mBCC
The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
LDE225 800mg mBCC
The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
| Group | Source count |
|---|---|
| LDE225 200mg laBCC | 66 |
| LDE225 800mg laBCC | 128 |
| LDE225 200mg mBCC | 13 |
| LDE225 800mg mBCC | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LDE225 200mg laBCC | 47.0 | Not reported | 34.6 | 59.7 | Not reported |
| LDE225 800mg laBCC | 35.2 | Not reported | 26.9 | 44.1 | Not reported |
| LDE225 200mg mBCC | 15.4 | Not reported | 1.9 | 45.4 | Not reported |
| LDE225 800mg mBCC | 17.4 | Not reported | 5.0 | 38.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.6
- upper Limit
- 59.7
- value
- 47.0
- group Id
- OG001
- lower Limit
- 26.9
- upper Limit
- 44.1
- value
- 35.2
- group Id
- OG002
- lower Limit
- 1.9
- upper Limit
- 45.4
- value
- 15.4
- group Id
- OG003
- lower Limit
- 5.0
- upper Limit
- 38.8
- value
- 17.4
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 23
- units
- Participants
- description
- ORR is the percentage of patient's objective response (ORR) by 6 months after starting LDE225 treatment. A responder was defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG000
- title
- LDE225 200mg laBCC
- description
- The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG001
- title
- LDE225 800mg laBCC
- description
- The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG002
- title
- LDE225 200mg mBCC
- description
- The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
- id
- OG003
- title
- LDE225 800mg mBCC
- param Type
- NUMBER
- population Description
- The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients).
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice