TriangleNCT01177397 · OUTCOME
Part A: Overall Response Rate
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
- 90% Confidence Interval
- Time frame
- From first dose up to tumor response (approximately 11 months)
What was measured
Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), and the International Working Group Criteria (IWC) for DLBCL. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. In Part A, participants with MM and participants with GBM were not evaluated for tumor response.
Analysis population: Participants who received treatment in Part A
Groups in this outcome
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
| Group | Source count |
|---|---|
| Part A: CC-223 7.5 mg | 1 |
| Part A: CC-223 15 mg | 2 |
| Part A: CC-223 30 mg | 9 |
| Part A: CC-223 45 mg | 9 |
| Part A: CC-223 60 mg | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CC-223 7.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: CC-223 15 mg | 0 | Not reported | NA | NA | Lower and upper limit not calculated due to insufficient number of events |
| Part A: CC-223 30 mg | 11.1 | Not reported | 0.6 | 42.9 | Not reported |
| Part A: CC-223 45 mg | 0 | Not reported | NA | NA | Lower and upper limit not calculated due to insufficient number of events |
| Part A: CC-223 60 mg | 0 | Not reported | NA | NA | Lower and upper limit not calculated due to insufficient number of events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- comment
- Lower and upper limit not calculated due to insufficient number of events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG002
- lower Limit
- 0.6
- upper Limit
- 42.9
- value
- 11.1
- comment
- Lower and upper limit not calculated due to insufficient number of events
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- Lower and upper limit not calculated due to insufficient number of events
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 7
- units
- Participants
- description
- Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), and the International Working Group Criteria (IWC) for DLBCL. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. In Part A, participants with MM and participants with GBM were not evaluated for tumor response.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG000
- title
- Part A: CC-223 7.5 mg
- description
- Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG001
- title
- Part A: CC-223 15 mg
- description
- Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG002
- title
- Part A: CC-223 30 mg
- description
- Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG003
- title
- Part A: CC-223 45 mg
- description
- Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG004
- title
- Part A: CC-223 60 mg
- param Type
- NUMBER
- population Description
- Participants who received treatment in Part A
- reporting Status
- POSTED
- time Frame
- From first dose up to tumor response (approximately 11 months)
- title
- Part A: Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice