TriangleNCT01970865 · OUTCOME
Time to Tumor Progression (TTP) and Intracranial TTP (Phase 2 and DDI Substudy)
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 first documentation of objective PD (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
Time to progression (TTP) was defined as the time from the first dose of study treatment to the first documentation of objective PD. Intracranial TTP was defined as the time from the first dose of study treatment to the date of the first documentation of objective progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases. 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. Results presented here were based on independent central review.
Analysis population: ITT analysis set was used for TTP determination and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; ITT participants with CNS metastases were analyzed for intracranial TTP.
Groups in this outcome
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only 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-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.
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases 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.
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
| Group | Source count |
|---|---|
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 65 |
| EXP-5 (Phase 2) | 46 |
| EXP-6 (Phase 2) | 47 |
| DDI Sub-study | 32 |
Reported measurements
TTP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 17.7 | Not reported | 12.5 | 40.5 | Not reported |
| EXP-2 (Phase 2) | 20.6 | Not reported | 5.5 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-3 (Phase 2) | 8.2 | Not reported | 5.5 | 12.5 | Not reported |
| EXP-4 (Phase 2) | 8.4 | Not reported | 5.6 | 13.7 | Not reported |
| EXP-5 (Phase 2) | 5.6 | Not reported | 4.0 | 8.3 | Not reported |
| EXP-6 (Phase 2) | 12.5 | Not reported | 8.2 | 26.2 | Not reported |
| DDI Sub-study | 5.7 | Not reported | 4.1 | 8.3 | Not reported |
Intracranial TTP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | NA | Not reported | NA | NA | Median and 95% CI could not be calculated due to insufficient number of participants with events. |
| EXP-2 (Phase 2) | NA | Not reported | NA | NA | Median and 95% CI could not be calculated due to insufficient number of participants with events. |
| EXP-3 (Phase 2) | NA | Not reported | 15.0 | NA | Median and Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-4 (Phase 2) | 22.1 | Not reported | 15.7 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-5 (Phase 2) | 16.4 | Not reported | 12.7 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-6 (Phase 2) | NA | Not reported | 34.5 | NA | Median and Upper limit could not be calculated due to insufficient number of participants with events. |
| DDI Sub-study | NA | Not reported | 6.9 | NA | Median and Upper limit could not be calculated due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.5
- upper Limit
- 40.5
- value
- 17.7
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- NA
- value
- 20.6
- group Id
- OG002
- lower Limit
- 5.5
- upper Limit
- 12.5
- value
- 8.2
- group Id
- OG003
- lower Limit
- 5.6
- upper Limit
- 13.7
- value
- 8.4
- group Id
- OG004
- lower Limit
- 4.0
- upper Limit
- 8.3
- value
- 5.6
- group Id
- OG005
- lower Limit
- 8.2
- upper Limit
- 26.2
- value
- 12.5
- group Id
- OG006
- lower Limit
- 4.1
- upper Limit
- 8.3
- value
- 5.7
- title
- TTP
- categories
- measurements
- comment
- Median and 95% CI could not be calculated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% CI could not be calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 15.0
- upper Limit
- NA
- value
- NA
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG003
- lower Limit
- 15.7
- upper Limit
- NA
- value
- 22.1
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG004
- lower Limit
- 12.7
- upper Limit
- NA
- value
- 16.4
- comment
- Median and Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG005
- lower Limit
- 34.5
- upper Limit
- NA
- value
- NA
- comment
- Median and Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG006
- lower Limit
- 6.9
- upper Limit
- NA
- value
- NA
- title
- Intracranial TTP
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 60
- group Id
- OG003
- value
- 65
- group Id
- OG004
- value
- 46
- group Id
- OG005
- value
- 47
- group Id
- OG006
- value
- 32
- units
- Participants
- description
- Time to progression (TTP) was defined as the time from the first dose of study treatment to the first documentation of objective PD. Intracranial TTP was defined as the time from the first dose of study treatment to the date of the first documentation of objective progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases. 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. Results presented here were based on independent central review.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only 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-1 (Phase 2)
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- title
- EXP-5 (Phase 2)
- description
- Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases 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
- OG005
- title
- EXP-6 (Phase 2)
- description
- Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
- id
- OG006
- title
- DDI Sub-study
- param Type
- MEDIAN
- population Description
- ITT analysis set was used for TTP determination and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; ITT participants with CNS metastases were analyzed for intracranial TTP.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment to the first documentation of objective PD (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
- title
- Time to Tumor Progression (TTP) and Intracranial TTP (Phase 2 and DDI Substudy)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice