TriangleNCT01970865 · OUTCOME
Time to Tumor Response (TTR) and Intracranial TTR (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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From first dose of study treatment to the first documentation of objective tumor response (CR or PR) (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 tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. 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. Results presented here were based on independent central review.
Analysis population: TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. 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) | 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
TTR
| 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) | 1.4 | Not reported | 1.2 | 5.4 | Not reported |
| EXP-2 (Phase 2) | 1.4 | Not reported | 1.2 | 18.0 | Not reported |
| EXP-3 (Phase 2) | 1.4 | Not reported | 1.1 | 16.6 | Not reported |
| EXP-4 (Phase 2) | 2.6 | Not reported | 1.2 | 16.4 | Not reported |
| EXP-5 (Phase 2) | 1.4 | Not reported | 1.2 | 9.3 | Not reported |
| EXP-6 (Phase 2) | 1.4 | Not reported | 1.3 | 29.7 | Not reported |
| DDI Sub-study | 1.4 | Not reported | 1.2 | 11.0 | Not reported |
Intracranial TTR
| 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) | 2.1 | Not reported | 1.2 | 2.8 | Not reported |
| EXP-2 (Phase 2) | 1.4 | Not reported | 1.2 | 1.5 | Not reported |
| EXP-3 (Phase 2) | 1.4 | Not reported | 1.1 | 5.7 | Not reported |
| EXP-4 (Phase 2) | 1.7 | Not reported | 1.2 | 17.5 | Not reported |
| EXP-5 (Phase 2) | 1.4 | Not reported | 1.2 | 10.6 | Not reported |
| EXP-6 (Phase 2) | 1.4 | Not reported | 1.2 | 28.9 | Not reported |
| DDI Sub-study | 2.0 | Not reported | 1.1 | 4.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 5.4
- value
- 1.4
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 18.0
- value
- 1.4
- group Id
- OG002
- lower Limit
- 1.1
- upper Limit
- 16.6
- value
- 1.4
- group Id
- OG003
- lower Limit
- 1.2
- upper Limit
- 16.4
- value
- 2.6
- group Id
- OG004
- lower Limit
- 1.2
- upper Limit
- 9.3
- value
- 1.4
- group Id
- OG005
- lower Limit
- 1.3
- upper Limit
- 29.7
- value
- 1.4
- group Id
- OG006
- lower Limit
- 1.2
- upper Limit
- 11.0
- value
- 1.4
- 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
- TTR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 2.8
- value
- 2.1
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 1.5
- value
- 1.4
- group Id
- OG002
- lower Limit
- 1.1
- upper Limit
- 5.7
- value
- 1.4
- group Id
- OG003
- lower Limit
- 1.2
- upper Limit
- 17.5
- value
- 1.7
- group Id
- OG004
- lower Limit
- 1.2
- upper Limit
- 10.6
- value
- 1.4
- group Id
- OG005
- lower Limit
- 1.2
- upper Limit
- 28.9
- value
- 1.4
- group Id
- OG006
- lower Limit
- 1.1
- upper Limit
- 4.2
- value
- 2.0
- 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
- Intracranial TTR
- 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
- Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. 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. Results presented here were based on independent central review.
- dispersion Type
- Full Range
- 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
- TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. Here, "Number Analyzed" signifies participants evaluable for specified rows.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment to the first documentation of objective tumor response (CR or PR) (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 Response (TTR) and Intracranial TTR (Phase 2 and DDI Sub-study)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice