TriangleNCT01970865 · OUTCOME
Time to Progression on the Last Prior Therapy (Phase 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose of study treatment to the date of progression (maximum of 7.5 years for Phase 2)
What was measured
TTP on the last prior therapy was defined as time from the first dose date of the last prior treatment regimen to the date of progression. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose.
Analysis population: ITT analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. As planned in SAP, this outcome measure was not analyzed for EXP-1 and EXP-6 groups. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Groups in this outcome
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
| Group | Source count |
|---|---|
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 65 |
| EXP-5 (Phase 2) | 46 |
Reported measurements
Prior systemic therapy before PF-06463922
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-2 (Phase 2) | 11.5 | Not reported | 7.2 | 19.6 | Not reported |
| EXP-3 (Phase 2) | 12.8 | Not reported | 10.9 | 16.9 | Not reported |
| EXP-4 (Phase 2) | 10.2 | Not reported | 7.6 | 15.9 | Not reported |
| EXP-5 (Phase 2) | 3.7 | Not reported | 2.1 | 6.4 | Not reported |
Prior ALK+/ROS1+ TKI treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-2 (Phase 2) | 11.5 | Not reported | 7.2 | 19.6 | Not reported |
| EXP-3 (Phase 2) | 13.8 | Not reported | 11.2 | 18.1 | Not reported |
| EXP-4 (Phase 2) | 12.1 | Not reported | 7.9 | 16.4 | Not reported |
| EXP-5 (Phase 2) | 3.7 | Not reported | 2.1 | 6.6 | Not reported |
Prior systemic therapy other than ALK+/ROS1+ TKI
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-2 (Phase 2) | 19.6 | Not reported | 16.1 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-3 (Phase 2) | 8.5 | Not reported | 5.0 | 12.6 | Not reported |
| EXP-4 (Phase 2) | 5.0 | Not reported | 3.1 | 10.0 | Not reported |
| EXP-5 (Phase 2) | 5.6 | Not reported | 3.5 | 11.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.2
- upper Limit
- 19.6
- value
- 11.5
- group Id
- OG001
- lower Limit
- 10.9
- upper Limit
- 16.9
- value
- 12.8
- group Id
- OG002
- lower Limit
- 7.6
- upper Limit
- 15.9
- value
- 10.2
- group Id
- OG003
- lower Limit
- 2.1
- upper Limit
- 6.4
- value
- 3.7
- title
- Prior systemic therapy before PF-06463922
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.2
- upper Limit
- 19.6
- value
- 11.5
- group Id
- OG001
- lower Limit
- 11.2
- upper Limit
- 18.1
- value
- 13.8
- group Id
- OG002
- lower Limit
- 7.9
- upper Limit
- 16.4
- value
- 12.1
- group Id
- OG003
- lower Limit
- 2.1
- upper Limit
- 6.6
- value
- 3.7
- title
- Prior ALK+/ROS1+ TKI treatment
- categories
- measurements
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 16.1
- upper Limit
- NA
- value
- 19.6
- group Id
- OG001
- lower Limit
- 5.0
- upper Limit
- 12.6
- value
- 8.5
- group Id
- OG002
- lower Limit
- 3.1
- upper Limit
- 10.0
- value
- 5.0
- group Id
- OG003
- lower Limit
- 3.5
- upper Limit
- 11.2
- value
- 5.6
- title
- Prior systemic therapy other than ALK+/ROS1+ TKI
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 65
- group Id
- OG003
- value
- 46
- units
- Participants
- description
- TTP on the last prior therapy was defined as time from the first dose date of the last prior treatment regimen to the date of progression. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG000
- title
- EXP-2 (Phase 2)
- description
- Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG001
- title
- EXP-3 (Phase 2)
- description
- Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG002
- title
- EXP-4 (Phase 2)
- description
- Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG003
- title
- EXP-5 (Phase 2)
- param Type
- MEDIAN
- population Description
- ITT analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. As planned in SAP, this outcome measure was not analyzed for EXP-1 and EXP-6 groups. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment to the date of progression (maximum of 7.5 years for Phase 2)
- title
- Time to Progression on the Last Prior Therapy (Phase 2)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice