NCT01970865 · OUTCOME
Number of Participants With Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
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 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. Hematology parameters with any abnormalities were reported in this outcome measure.
Analysis population: The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922. Here 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
Groups in this outcome
10 mg QD (Phase 1)
PF-06463922 10 mg was orally given once daily (QD) on Day -7 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.
25 mg QD (Phase 1)
PF-06463922 25 mg was orally given QD 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. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 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.
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 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.
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 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.
150 mg QD (Phase 1)
PF-06463922 150 mg was orally given QD 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. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 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.
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 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.
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 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.
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 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-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 |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 47 |
| DDI Sub-study | 32 |
Reported measurements
Anemia
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 47 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 10 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 16 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 24 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 22 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 51 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 52 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 35 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 34 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 25 | Not reported | Not reported | Not reported | Not reported |
Hemoglobin increased
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 47 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 0 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 3 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 1 | Not reported | Not reported | Not reported | Not reported |
Lymphocyte count decreased
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 46 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 7 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 12 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 14 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 30 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 31 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 21 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 26 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 15 | Not reported | Not reported | Not reported | Not reported |
Lymphocyte count increased
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 46 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 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) | 6 | 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 2 | Not reported | Not reported | Not reported | Not reported |
Neutrophil count decreased
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 46 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 7 | 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) | 10 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 2 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 7 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 3 | Not reported | Not reported | Not reported | Not reported |
Platelet count decreased
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 47 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 5 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 8 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 10 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 18 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 12 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 13 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 13 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 8 | Not reported | Not reported | Not reported | Not reported |
White blood cell decreased
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 12 |
| 100 mg QD (Phase 1) | 17 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 3 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 4 |
| EXP-1 (Phase 2) | 30 |
| EXP-2 (Phase 2) | 27 |
| EXP-3 (Phase 2) | 60 |
| EXP-4 (Phase 2) | 64 |
| EXP-5 (Phase 2) | 45 |
| EXP-6 (Phase 2) | 47 |
| DDI Sub-study | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| EXP-1 (Phase 2) | 9 | Not reported | Not reported | Not reported | Not reported |
| EXP-2 (Phase 2) | 5 | Not reported | Not reported | Not reported | Not reported |
| EXP-3 (Phase 2) | 9 | Not reported | Not reported | Not reported | Not reported |
| EXP-4 (Phase 2) | 13 | Not reported | Not reported | Not reported | Not reported |
| EXP-5 (Phase 2) | 8 | Not reported | Not reported | Not reported | Not reported |
| EXP-6 (Phase 2) | 10 | Not reported | Not reported | Not reported | Not reported |
| DDI Sub-study | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 24
- group Id
- OG011
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- title
- Hemoglobin increased
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 12
- group Id
- OG011
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- title
- Lymphocyte count decreased
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- title
- Lymphocyte count increased
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- title
- Neutrophil count decreased
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 8
- group Id
- OG011
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- title
- Platelet count decreased
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- title
- White blood cell decreased
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 30
- group Id
- OG011
- value
- 27
- units
- Participants
- description
- Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. Hematology parameters with any abnormalities were reported in this outcome measure.
- groups
- description
- PF-06463922 10 mg was orally given once daily (QD) on Day -7 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
- 10 mg QD (Phase 1)
- description
- PF-06463922 25 mg was orally given QD 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. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG001
- title
- 25 mg QD (Phase 1)
- description
- PF-06463922 50 mg was orally given QD on Day -7 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
- 50 mg QD (Phase 1)
- description
- PF-06463922 75 mg was orally given QD on Day -7 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
- 75 mg QD (Phase 1)
- description
- PF-06463922 100 mg was orally given QD on Day -7 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
- 100 mg QD (Phase 1)
- description
- PF-06463922 150 mg was orally given QD 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. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG005
- title
- 150 mg QD (Phase 1)
- description
- PF-06463922 200 mg was orally given QD on Day -7 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
- OG006
- title
- 200 mg QD (Phase 1)
- description
- PF-06463922 35 mg was orally given twice daily (BID) on Day -7 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
- OG007
- title
- 35 mg BID (Phase 1)
- description
- PF-06463922 75 mg was orally given BID on Day -7 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
- OG008
- title
- 75 mg BID (Phase 1)
- description
- PF-06463922 100 mg was orally given BID on Day -7 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
- OG009
- title
- 100 mg BID (Phase 1)
- 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
- OG010
- 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
- OG011
- title
- EXP-2 (Phase 2)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922. Here 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and '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 8 years for Phase 1, 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 Laboratory Abnormalities (Phase 1, Phase 2 and DDI Sub-study) - Hematology
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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