TriangleNCT00084682 · OUTCOME
Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years
What was measured
Tumor response was assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as 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. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance of new lesions or \>/= 30% increase in target lesions) at 8 weeks.
Groups in this outcome
Treatment (Romidepsin)
Patients receive FR901228 (depsipeptide) IV at 13 mg/m\^2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV
| Group | Source count |
|---|---|
| Treatment (Romidepsin) | 13 |
Reported measurements
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Romidepsin) | 2 | Not reported | 1.9 | 45.5 | Not reported |
Disease progression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Romidepsin) | 9 | Not reported | 1.9 | 45.5 | Not reported |
Symptomatic deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Romidepsin) | 2 | Not reported | 1.9 | 45.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 45.5
- value
- 2
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 45.5
- value
- 9
- title
- Disease progression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 45.5
- value
- 2
- title
- Symptomatic deterioration
- denoms
- counts
- group Id
- OG000
- value
- 13
- units
- Participants
- description
- Tumor response was assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as 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. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance of new lesions or \>/= 30% increase in target lesions) at 8 weeks.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive FR901228 (depsipeptide) IV at 13 mg/m\^2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV
- id
- OG000
- title
- Treatment (Romidepsin)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice