TriangleNCT01970865 · OUTCOME
Percentage of Participants Achieving Disease Control and Intracranial Disease Control at Week 12 and 24 (Phase 2 and DDI Substudy)
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
- Weeks 12 and 24
What was measured
Tumor response was evaluated according to RECIST version 1.1, and disease control was defined as confirmed CR, confirmed PR, or stable disease (SD). 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. SD= when neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD is observed, taking as reference the smallest sum diameters while on study. Intracranial assessment was only performed for participants CNS metastases. 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. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
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
Disease control rate at Week 12
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 93.3 | Not reported | 77.9 | 99.2 | Not reported |
| EXP-2 (Phase 2) | 85.2 | Not reported | 66.3 | 95.8 | Not reported |
| EXP-3 (Phase 2) | 68.3 | Not reported | 55.0 | 79.7 | Not reported |
| EXP-4 (Phase 2) | 64.6 | Not reported | 51.8 | 76.1 | Not reported |
| EXP-5 (Phase 2) | 50.0 | Not reported | 34.9 | 65.1 | Not reported |
| EXP-6 (Phase 2) | 66.0 | Not reported | 50.7 | 79.1 | Not reported |
| DDI Sub-study | 56.3 | Not reported | 37.7 | 73.6 | Not reported |
Disease control rate at Week 24
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 83.3 | Not reported | 65.3 | 94.4 | Not reported |
| EXP-2 (Phase 2) | 63.0 | Not reported | 42.4 | 80.6 | Not reported |
| EXP-3 (Phase 2) | 51.7 | Not reported | 38.4 | 64.8 | Not reported |
| EXP-4 (Phase 2) | 49.2 | Not reported | 36.6 | 61.9 | Not reported |
| EXP-5 (Phase 2) | 32.6 | Not reported | 19.5 | 48.0 | Not reported |
| EXP-6 (Phase 2) | 48.9 | Not reported | 34.1 | 63.9 | Not reported |
| DDI Sub-study | 34.4 | Not reported | 18.6 | 53.2 | Not reported |
Intra-cranial disease control rate at Week 12
| Group | Source count |
|---|---|
| EXP-1 (Phase 2) | 8 |
| EXP-2 (Phase 2) | 17 |
| EXP-3 (Phase 2) | 33 |
| EXP-4 (Phase 2) | 45 |
| EXP-5 (Phase 2) | 37 |
| EXP-6 (Phase 2) | 25 |
| DDI Sub-study | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 87.5 | Not reported | 47.3 | 99.7 | Not reported |
| EXP-2 (Phase 2) | 94.1 | Not reported | 71.3 | 99.9 | Not reported |
| EXP-3 (Phase 2) | 75.8 | Not reported | 57.7 | 88.9 | Not reported |
| EXP-4 (Phase 2) | 75.6 | Not reported | 60.5 | 87.1 | Not reported |
| EXP-5 (Phase 2) | 67.6 | Not reported | 50.2 | 82.0 | Not reported |
| EXP-6 (Phase 2) | 72.0 | Not reported | 50.6 | 87.9 | Not reported |
| DDI Sub-study | 56.3 | Not reported | 29.9 | 80.2 | Not reported |
Intra-cranial disease control rate at Week 24
| Group | Source count |
|---|---|
| EXP-1 (Phase 2) | 8 |
| EXP-2 (Phase 2) | 17 |
| EXP-3 (Phase 2) | 33 |
| EXP-4 (Phase 2) | 45 |
| EXP-5 (Phase 2) | 37 |
| EXP-6 (Phase 2) | 25 |
| DDI Sub-study | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 75.0 | Not reported | 34.9 | 96.8 | Not reported |
| EXP-2 (Phase 2) | 70.6 | Not reported | 44.0 | 89.7 | Not reported |
| EXP-3 (Phase 2) | 60.6 | Not reported | 42.1 | 77.1 | Not reported |
| EXP-4 (Phase 2) | 62.2 | Not reported | 46.5 | 76.2 | Not reported |
| EXP-5 (Phase 2) | 48.6 | Not reported | 31.9 | 65.6 | Not reported |
| EXP-6 (Phase 2) | 52.0 | Not reported | 31.3 | 72.2 | Not reported |
| DDI Sub-study | 43.8 | Not reported | 19.8 | 70.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.9
- upper Limit
- 99.2
- value
- 93.3
- group Id
- OG001
- lower Limit
- 66.3
- upper Limit
- 95.8
- value
- 85.2
- group Id
- OG002
- lower Limit
- 55.0
- upper Limit
- 79.7
- value
- 68.3
- group Id
- OG003
- lower Limit
- 51.8
- upper Limit
- 76.1
- value
- 64.6
- group Id
- OG004
- lower Limit
- 34.9
- upper Limit
- 65.1
- value
- 50.0
- group Id
- OG005
- lower Limit
- 50.7
- upper Limit
- 79.1
- value
- 66.0
- group Id
- OG006
- lower Limit
- 37.7
- upper Limit
- 73.6
- value
- 56.3
- 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
- title
- Disease control rate at Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.3
- upper Limit
- 94.4
- value
- 83.3
- group Id
- OG001
- lower Limit
- 42.4
- upper Limit
- 80.6
- value
- 63.0
- group Id
- OG002
- lower Limit
- 38.4
- upper Limit
- 64.8
- value
- 51.7
- group Id
- OG003
- lower Limit
- 36.6
- upper Limit
- 61.9
- value
- 49.2
- group Id
- OG004
- lower Limit
- 19.5
- upper Limit
- 48.0
- value
- 32.6
- group Id
- OG005
- lower Limit
- 34.1
- upper Limit
- 63.9
- value
- 48.9
- group Id
- OG006
- lower Limit
- 18.6
- upper Limit
- 53.2
- value
- 34.4
- 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
- title
- Disease control rate at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 47.3
- upper Limit
- 99.7
- value
- 87.5
- group Id
- OG001
- lower Limit
- 71.3
- upper Limit
- 99.9
- value
- 94.1
- group Id
- OG002
- lower Limit
- 57.7
- upper Limit
- 88.9
- value
- 75.8
- group Id
- OG003
- lower Limit
- 60.5
- upper Limit
- 87.1
- value
- 75.6
- group Id
- OG004
- lower Limit
- 50.2
- upper Limit
- 82.0
- value
- 67.6
- group Id
- OG005
- lower Limit
- 50.6
- upper Limit
- 87.9
- value
- 72.0
- group Id
- OG006
- lower Limit
- 29.9
- upper Limit
- 80.2
- value
- 56.3
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 33
- group Id
- OG003
- value
- 45
- group Id
- OG004
- value
- 37
- group Id
- OG005
- value
- 25
- group Id
- OG006
- value
- 16
- units
- Participants
- title
- Intra-cranial disease control rate at Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.9
- upper Limit
- 96.8
- value
- 75.0
- group Id
- OG001
- lower Limit
- 44.0
- upper Limit
- 89.7
- value
- 70.6
- group Id
- OG002
- lower Limit
- 42.1
- upper Limit
- 77.1
- value
- 60.6
- group Id
- OG003
- lower Limit
- 46.5
- upper Limit
- 76.2
- value
- 62.2
- group Id
- OG004
- lower Limit
- 31.9
- upper Limit
- 65.6
- value
- 48.6
- group Id
- OG005
- lower Limit
- 31.3
- upper Limit
- 72.2
- value
- 52.0
- group Id
- OG006
- lower Limit
- 19.8
- upper Limit
- 70.1
- value
- 43.8
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 33
- group Id
- OG003
- value
- 45
- group Id
- OG004
- value
- 37
- group Id
- OG005
- value
- 25
- group Id
- OG006
- value
- 16
- units
- Participants
- title
- Intra-cranial disease control rate at Week 24
- 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
- Tumor response was evaluated according to RECIST version 1.1, and disease control was defined as confirmed CR, confirmed PR, or stable disease (SD). 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. SD= when neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD is observed, taking as reference the smallest sum diameters while on study. Intracranial assessment was only performed for participants CNS metastases. 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
- 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. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
- reporting Status
- POSTED
- time Frame
- Weeks 12 and 24
- title
- Percentage of Participants Achieving Disease Control and Intracranial Disease Control at Week 12 and 24 (Phase 2 and DDI Substudy)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice