TriangleNCT01125293 · OUTCOME
PTEN Mutation Rate [Phase II]
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
- Samples were collected pre-therapy before the beginning therapy (baseline) and post-therapy after finishing the 6th treatment cycle (168 days).
What was measured
The PTEN mutation rate is the percentage of patients with PTEN mutation identified in pre-therapy and post-therapy bone marrow samples per established methods.
Analysis population: The correlative objective for the study was to identify molecular regulators of response/resistance. Because the study terminated early with limited efficacy shown in the stage 1 cohort correlative objectives could not be met. Bone marrow and peripheral blood samples were collected pre- and post-therapy for phase II patients but only a few experiments conducted considering resources and the limited potential interpretation.
Groups in this outcome
Phase II
Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
| Group | Source count |
|---|---|
| Phase II | 20 |
Reported measurements
MYD88/L265P mutation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II | 80 | Not reported | 56 | 94 | Not reported |
CXCR4/C1013G mutation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II | 5 | Not reported | 0 | 25 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56
- upper Limit
- 94
- value
- 80
- title
- MYD88/L265P mutation
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 25
- value
- 5
- title
- CXCR4/C1013G mutation
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- The PTEN mutation rate is the percentage of patients with PTEN mutation identified in pre-therapy and post-therapy bone marrow samples per established methods.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
- id
- OG000
- title
- Phase II
- param Type
- NUMBER
- population Description
- The correlative objective for the study was to identify molecular regulators of response/resistance. Because the study terminated early with limited efficacy shown in the stage 1 cohort correlative objectives could not be met. Bone marrow and peripheral blood samples were collected pre- and post-therapy for phase II patients but only a few experiments conducted considering resources and the limited potential interpretation.
- reporting Status
- POSTED
- time Frame
- Samples were collected pre-therapy before the beginning therapy (baseline) and post-therapy after finishing the 6th treatment cycle (168 days).
- title
- PTEN Mutation Rate [Phase II]
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice