TriangleNCT01970865 · OUTCOME
Percentage of Participants With Overall and Intracranial Objective Response (Phase 2 and DDI Sub-study)
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
- From first dose of study treatment to end of treatment maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 milliliter (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 percent (%) or more decrease in sum of lesion dimensions (SLD) of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review.
Analysis population: 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 central nervous system (CNS) metastases in the ITT analysis set were 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.
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 |
| Phase 2 | 47 |
| DDI Sub-study | 32 |
Reported measurements
Objective response
| 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 |
| Phase 2 | 47 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 90.0 | Not reported | 73.5 | 97.9 | Not reported |
| EXP-2 (Phase 2) | 77.8 | Not reported | 57.7 | 91.4 | Not reported |
| EXP-3 (Phase 2) | 56.7 | Not reported | 43.2 | 69.4 | Not reported |
| EXP-4 (Phase 2) | 40.0 | Not reported | 28.0 | 52.9 | Not reported |
| EXP-5 (Phase 2) | 37.0 | Not reported | 23.2 | 52.5 | Not reported |
| Phase 2 | 38.3 | Not reported | 24.5 | 53.6 | Not reported |
| DDI Sub-study | 40.6 | Not reported | 23.7 | 59.4 | Not reported |
Intracranial objective response
| 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 |
| 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) | 58.8 | Not reported | 32.9 | 81.6 | Not reported |
| EXP-3 (Phase 2) | 66.7 | Not reported | 48.2 | 82.0 | Not reported |
| EXP-4 (Phase 2) | 53.3 | Not reported | 37.9 | 68.3 | Not reported |
| EXP-5 (Phase 2) | 43.2 | Not reported | 27.1 | 60.5 | Not reported |
| Phase 2 | 56.0 | Not reported | 34.9 | 75.6 | Not reported |
| DDI Sub-study | 25.0 | Not reported | 7.3 | 52.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.5
- upper Limit
- 97.9
- value
- 90.0
- group Id
- OG001
- lower Limit
- 57.7
- upper Limit
- 91.4
- value
- 77.8
- group Id
- OG002
- lower Limit
- 43.2
- upper Limit
- 69.4
- value
- 56.7
- group Id
- OG003
- lower Limit
- 28.0
- upper Limit
- 52.9
- value
- 40.0
- group Id
- OG004
- lower Limit
- 23.2
- upper Limit
- 52.5
- value
- 37.0
- group Id
- OG005
- lower Limit
- 24.5
- upper Limit
- 53.6
- value
- 38.3
- group Id
- OG006
- lower Limit
- 23.7
- upper Limit
- 59.4
- value
- 40.6
- 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
- Objective response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.9
- upper Limit
- 96.8
- value
- 75.0
- group Id
- OG001
- lower Limit
- 32.9
- upper Limit
- 81.6
- value
- 58.8
- group Id
- OG002
- lower Limit
- 48.2
- upper Limit
- 82.0
- value
- 66.7
- group Id
- OG003
- lower Limit
- 37.9
- upper Limit
- 68.3
- value
- 53.3
- group Id
- OG004
- lower Limit
- 27.1
- upper Limit
- 60.5
- value
- 43.2
- group Id
- OG005
- lower Limit
- 34.9
- upper Limit
- 75.6
- value
- 56.0
- group Id
- OG006
- lower Limit
- 7.3
- upper Limit
- 52.4
- value
- 25.0
- 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
- Intracranial objective response
- 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
- Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 milliliter (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 percent (%) or more decrease in sum of lesion dimensions (SLD) of target lesions, taking as reference the baseline SLD. 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
- 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
- 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 central nervous system (CNS) metastases in the ITT analysis set were used for intracranial response assessment. Here, "Number Analyzed" signifies participants evaluable for specified rows.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment to end of treatment maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
- title
- Percentage of Participants With Overall and Intracranial Objective Response (Phase 2 and DDI Sub-study)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice