TriangleNCT01970865 · OUTCOME
Time to Tumor Response (TTR) and Intracranial TTR (Phase 1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From start of study treatment to the first documentation of objective tumor response (CR or PR) (maximum of 8 years approximately)
What was measured
Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.
Analysis population: TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.
Groups in this outcome
ALK Positive Population (Phase 1)
This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
ROS1 Positive Population (Phase 1)
This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
| Group | Source count |
|---|---|
| ALK Positive Population (Phase 1) | 16 |
| ROS1 Positive Population (Phase 1) | 6 |
Reported measurements
TTR
| Group | Source count |
|---|---|
| ALK Positive Population (Phase 1) | 16 |
| ROS1 Positive Population (Phase 1) | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALK Positive Population (Phase 1) | 1.4 | Not reported | 1.2 | 15.2 | Not reported |
| ROS1 Positive Population (Phase 1) | 1.4 | Not reported | 1.2 | 2.8 | Not reported |
Intracranial TTR
| Group | Source count |
|---|---|
| ALK Positive Population (Phase 1) | 14 |
| ROS1 Positive Population (Phase 1) | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALK Positive Population (Phase 1) | 1.4 | Not reported | 1.2 | 20.1 | Not reported |
| ROS1 Positive Population (Phase 1) | 1.4 | Not reported | 1.1 | 2.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 15.2
- value
- 1.4
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 2.8
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- TTR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 20.1
- value
- 1.4
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 2.8
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Intracranial TTR
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.
- dispersion Type
- Full Range
- groups
- description
- This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
- id
- OG000
- title
- ALK Positive Population (Phase 1)
- description
- This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
- id
- OG001
- title
- ROS1 Positive Population (Phase 1)
- param Type
- MEDIAN
- population Description
- TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.
- reporting Status
- POSTED
- time Frame
- From start of study treatment to the first documentation of objective tumor response (CR or PR) (maximum of 8 years approximately)
- title
- Time to Tumor Response (TTR) and Intracranial TTR (Phase 1)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice