TriangleNCT00561418 · OUTCOME
Clinical Benefit
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- patients
- Interval / dispersion
- Not reported
- Time frame
- Up to 3 years
What was measured
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Analysis population: Response following AHSCT
Groups in this outcome
Vorinostat (SAHA)
Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)
| Group | Source count |
|---|---|
| Vorinostat (SAHA) | 23 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 13 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 3 | Not reported | Not reported | Not reported | Not reported |
Stable Disease(SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 2 | Not reported | Not reported | Not reported | Not reported |
Not evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat (SAHA) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Stable Disease(SD)
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- Not evaluable
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- groups
- description
- Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)
- id
- OG000
- title
- Vorinostat (SAHA)
- param Type
- NUMBER
- population Description
- Response following AHSCT
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Clinical Benefit
- type
- SECONDARY
- unit Of Measure
- patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice