TriangleNCT01970865 · OUTCOME
Duration of Response (DOR) and Intracranial DOR (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 first documentation of PD or to death due to any cause, whichever occurred first (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
Duration of response(DOR): time from first documentation of objective tumor response (CR/PR) to first documentation of PD or to death due to any cause, whichever occurred first. DOR: calculated for subgroup of participants with confirmed objective tumor response. Intracranial DOR: calculated for participants with confirmed intracranial objective response. CR:disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesion eCRF). Any pathological lymph node (recorded as target lesion) must have reduction in short axis to \<10mm. PR:30% or more decrease in SLD of target lesion, taking as reference baseline SLD. PD:20% or more increase in the SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition, also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
Analysis population: DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.
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) | 27 |
| EXP-2 (Phase 2) | 21 |
| EXP-3 (Phase 2) | 34 |
| EXP-4 (Phase 2) | 26 |
| EXP-5 (Phase 2) | 17 |
| EXP-6 (Phase 2) | 18 |
| DDI Sub-study | 13 |
Reported measurements
DOR
| Group | Source count |
|---|---|
| EXP-1 (Phase 2) | 27 |
| EXP-2 (Phase 2) | 21 |
| EXP-3 (Phase 2) | 34 |
| EXP-4 (Phase 2) | 26 |
| EXP-5 (Phase 2) | 17 |
| EXP-6 (Phase 2) | 18 |
| DDI Sub-study | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 17.16 | Not reported | 12.45 | 35.09 | Not reported |
| EXP-2 (Phase 2) | 16.56 | Not reported | 4.20 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-3 (Phase 2) | 11.10 | Not reported | 5.55 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-4 (Phase 2) | 15.08 | Not reported | 5.55 | 26.28 | Not reported |
| EXP-5 (Phase 2) | 7.03 | Not reported | 4.17 | 11.01 | Not reported |
| EXP-6 (Phase 2) | 19.61 | Not reported | 11.10 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| DDI Sub-study | 5.19 | Not reported | 4.17 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
Intra-cranial DOR
| Group | Source count |
|---|---|
| EXP-1 (Phase 2) | 6 |
| EXP-2 (Phase 2) | 10 |
| EXP-3 (Phase 2) | 22 |
| EXP-4 (Phase 2) | 24 |
| EXP-5 (Phase 2) | 16 |
| EXP-6 (Phase 2) | 14 |
| DDI Sub-study | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | NA | Not reported | 8.28 | NA | Median and Upper limit could not be calculated due to insufficient number of participants with events.. |
| EXP-2 (Phase 2) | NA | Not reported | 20.99 | NA | Median and Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-3 (Phase 2) | 37.12 | Not reported | 8.38 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-4 (Phase 2) | 14.52 | Not reported | 11.07 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| EXP-5 (Phase 2) | 10.32 | Not reported | 6.90 | 14.98 | Not reported |
| EXP-6 (Phase 2) | 17.62 | Not reported | 4.99 | NA | Upper limit could not be calculated due to insufficient number of participants with events. |
| DDI Sub-study | NA | Not reported | 2.76 | 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
- 12.45
- upper Limit
- 35.09
- value
- 17.16
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 4.20
- upper Limit
- NA
- value
- 16.56
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 5.55
- upper Limit
- NA
- value
- 11.10
- group Id
- OG003
- lower Limit
- 5.55
- upper Limit
- 26.28
- value
- 15.08
- group Id
- OG004
- lower Limit
- 4.17
- upper Limit
- 11.01
- value
- 7.03
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG005
- lower Limit
- 11.10
- upper Limit
- NA
- value
- 19.61
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG006
- lower Limit
- 4.17
- upper Limit
- NA
- value
- 5.19
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 13
- units
- Participants
- title
- DOR
- categories
- measurements
- comment
- Median and Upper limit could not be calculated due to insufficient number of participants with events..
- group Id
- OG000
- lower Limit
- 8.28
- upper Limit
- NA
- value
- NA
- comment
- Median and Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 20.99
- upper Limit
- NA
- value
- NA
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 8.38
- upper Limit
- NA
- value
- 37.12
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG003
- lower Limit
- 11.07
- upper Limit
- NA
- value
- 14.52
- group Id
- OG004
- lower Limit
- 6.90
- upper Limit
- 14.98
- value
- 10.32
- comment
- Upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG005
- lower Limit
- 4.99
- upper Limit
- NA
- value
- 17.62
- comment
- Median and upper limit could not be calculated due to insufficient number of participants with events.
- group Id
- OG006
- lower Limit
- 2.76
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 24
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 4
- units
- Participants
- title
- Intra-cranial DOR
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 13
- units
- Participants
- description
- Duration of response(DOR): time from first documentation of objective tumor response (CR/PR) to first documentation of PD or to death due to any cause, whichever occurred first. DOR: calculated for subgroup of participants with confirmed objective tumor response. Intracranial DOR: calculated for participants with confirmed intracranial objective response. CR:disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesion eCRF). Any pathological lymph node (recorded as target lesion) must have reduction in short axis to \<10mm. PR:30% or more decrease in SLD of target lesion, taking as reference baseline SLD. PD:20% or more increase in the SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition, also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
- 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
- DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
- title
- Duration of Response (DOR) and Intracranial DOR (Phase 2 and DDI Substudy)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice