NCT01970865 · OUTCOME
Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- 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
PR Interval was determined by ECG measurement. PR interval had following categories: change from baseline\>=25 percent, 40 to \<60 milliseconds (msec), 60 to \<80 msec and \>=80 msec. Baseline was defined as the average of the triplicate measurements prior to the first dose of study drug.
Analysis population: Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. Here, "Overall Number of Participants Analyzed": participants evaluable 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 Substudy
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) | 29 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 59 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 46 |
| EXP-6 (Phase 2) | 47 |
| DDI Substudy | 32 |
Reported measurements
Change from baseline: >25%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 4 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 8 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 9 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 6 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 10 | Not reported | Not reported | Not reported | Not reported |
| DDI Substudy | 2 | Not reported | Not reported | Not reported | Not reported |
Absolute value: 40-<60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 7 | Not reported | Not reported | Not reported | Not reported |
| DDI Substudy | 2 | Not reported | Not reported | Not reported | Not reported |
Absolute value: 60-<80 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 4 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| DDI Substudy | 0 | Not reported | Not reported | Not reported | Not reported |
Absolute value: >=80 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EXP-1 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| DDI Substudy | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 2
- title
- Change from baseline: >25%
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 2
- title
- Absolute value: 40-<60 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- title
- Absolute value: 60-<80 msec
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- title
- Absolute value: >=80 msec
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 59
- group Id
- OG003
- value
- 64
- group Id
- OG004
- value
- 46
- group Id
- OG005
- value
- 47
- group Id
- OG006
- value
- 32
- units
- Participants
- description
- PR Interval was determined by ECG measurement. PR interval had following categories: change from baseline\>=25 percent, 40 to \<60 milliseconds (msec), 60 to \<80 msec and \>=80 msec. Baseline was defined as the average of the triplicate measurements prior to the first dose of study drug.
- 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 Substudy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. Here, "Overall Number of Participants Analyzed": participants evaluable for this outcome measure.
- 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
- Number of Participants With Absolute Values and Change From Baseline in PR Interval Meeting Pre-defined Criteria (Phase 2 and DDI Substudy)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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