TriangleNCT02254551 · OUTCOME
Maximum Tolerated Dose (MTD) of LDE225 Plus Bortezomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- every 3 weeks up to 48 weeks
What was measured
During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.
Groups in this outcome
LDE225 Plus Bortezomib
Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity
| Group | Source count |
|---|---|
| LDE225 Plus Bortezomib | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LDE225 Plus Bortezomib | NA | Not reported | Not reported | Not reported | The MTD was not reached. Due to lack of efficacy and toxicity seen during dose level 1, additional dose levels were not examined and the study was terminated. |
Complete source fields
- classes
- categories
- measurements
- comment
- The MTD was not reached. Due to lack of efficacy and toxicity seen during dose level 1, additional dose levels were not examined and the study was terminated.
- group Id
- OG000
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- description
- During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.
- groups
- description
- Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity
- id
- OG000
- title
- LDE225 Plus Bortezomib
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- every 3 weeks up to 48 weeks
- title
- Maximum Tolerated Dose (MTD) of LDE225 Plus Bortezomib
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice