NCT02780804 · OUTCOME
Antitumor Activity of Entinostat
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 4 years 9 months
What was measured
Frequency of response to entinostat per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and/or 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, stratified by study part and dose
Analysis population: All eligible enrolled patients.
Groups in this outcome
Stratum 1 With 3 mg/m²
Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
Stratum 1 With 4 mg/m²
Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
PK Part With 4 mg/m²
Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
| Group | Source count |
|---|---|
| Stratum 1 With 3 mg/m² | 6 |
| Stratum 1 With 4 mg/m² | 9 |
| PK Part With 4 mg/m² | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 With 3 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 With 4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| PK Part With 4 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Frequency of response to entinostat per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and/or 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, stratified by study part and dose
- groups
- description
- Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
- id
- OG000
- title
- Stratum 1 With 3 mg/m²
- description
- Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
- id
- OG001
- title
- Stratum 1 With 4 mg/m²
- description
- Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
- id
- OG002
- title
- PK Part With 4 mg/m²
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All eligible enrolled patients.
- reporting Status
- POSTED
- time Frame
- Up to 4 years 9 months
- title
- Antitumor Activity of Entinostat
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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