NCT01970865 · OUTCOME
Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1)
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12
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
- 95% Confidence Interval
- Time frame
- 12 and 24 weeks
What was measured
Tumor response was evaluated according to RECIST version 1.1, and disease control: confirmed CR, confirmed PR, or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. CR was defined as disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm 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 30% or more decrease in SLD of target lesions, taking as reference baseline SLD. Progressive disease: 20% or more increase in SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition to relative increase of 20%, SLD must also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose. Results presented here were based on independent central review.
Analysis population: The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 41 |
|---|
| ROS1 Positive Population (Phase 1) | 12 |
|---|
Reported measurements
DCR at Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 41 |
|---|
| ROS1 Positive Population (Phase 1) | 12 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 53.7 | Not reported | 37.4 | 69.3 | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 58.3 | Not reported | 27.7 | 84.8 | Not reported |
|---|
DCR at Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 41 |
|---|
| ROS1 Positive Population (Phase 1) | 12 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 39.0 | Not reported | 24.2 | 55.5 | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 50.0 | Not reported | 21.1 | 78.9 | Not reported |
|---|
Intracranial DCR at Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 34 |
|---|
| ROS1 Positive Population (Phase 1) | 8 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 50.0 | Not reported | 32.4 | 67.6 | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 37.5 | Not reported | 8.5 | 75.5 | Not reported |
|---|
Intracranial DCR at Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| ALK Positive Population (Phase 1) | 34 |
|---|
| ROS1 Positive Population (Phase 1) | 8 |
|---|
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| ALK Positive Population (Phase 1) | 41.2 | Not reported | 24.6 | 59.3 | Not reported |
|---|
| ROS1 Positive Population (Phase 1) | 37.5 | Not reported | 8.5 | 75.5 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 37.4
- upper Limit
- 69.3
- value
- 53.7
- group Id
- OG001
- lower Limit
- 27.7
- upper Limit
- 84.8
- value
- 58.3
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- DCR at Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.2
- upper Limit
- 55.5
- value
- 39.0
- group Id
- OG001
- lower Limit
- 21.1
- upper Limit
- 78.9
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- DCR at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.4
- upper Limit
- 67.6
- value
- 50.0
- group Id
- OG001
- lower Limit
- 8.5
- upper Limit
- 75.5
- value
- 37.5
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Intracranial DCR at Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.6
- upper Limit
- 59.3
- value
- 41.2
- group Id
- OG001
- lower Limit
- 8.5
- upper Limit
- 75.5
- value
- 37.5
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Intracranial DCR at Week 24
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Tumor response was evaluated according to RECIST version 1.1, and disease control: confirmed CR, confirmed PR, or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. CR was defined as disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm 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 30% or more decrease in SLD of target lesions, taking as reference baseline SLD. Progressive disease: 20% or more increase in SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition to relative increase of 20%, SLD must also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose. Results presented here were based on independent central review.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.
- reporting Status
- POSTED
- time Frame
- 12 and 24 weeks
- title
- Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice
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