Antineoplastic Agents

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Amino Acids

Crizotinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

crizotinib

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This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer patients with mild, moderate or severe liver dysfunction as well as patients with normal liver function will be enrolled in this study.

Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients

A Phase I Study To Evaluate The Effect Of Hepatic Impairment On The Pharmacokinetics And Safety Of Crizotinib In Advanced Cancer Patients

AUCdaily of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.

Unbound AUCdaily of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure, where AUCdaily was area under the plasma concentration time curve as daily exposure post-dose.

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 4 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events \[CTCAE\] Version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 4 years that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious adverse events.

Anemia(grade\[g\]1:Less than\[\<\] Lower limit of normal\[LLN\] to 10gram per\[/\] deciliter\[g/dL\],g2:\<10 to 8g/dL,g3:\<8g/dL,g4:lifethreatening);platelet (g1:\<LLN to 75\*10\^3/millimeter\[mm\]\^3,g2:\<75\*10\^3/mm\^3 to 50\*10\^3/mm\^3,g3:\<50\*10\^3/mm\^3 to 25\*10\^3/mm\^3,g4:\<25\*10\^3/mm\^3);lymphopenia(g1:\<LLN to 8\*10\^2/mm\^3,g2:\<8\*10\^2 to 5\*10\^2/mm\^3,g3:\<5\*10\^2 to 2\*10\^2/mm\^3,g4:\<2\*10\^2/mm\^3);neutrophil (Absolute)(g1:\<LLN to 15\*10\^2/mm\^3,g2:\<15\*10\^2 to 10\*10\^2/mm\^3,g3:\<10\*10\^2 to 5\*10\^2/mm\^3,g4:\<5\*10\^2/mm\^3);white blood cell count(g1:\<LLN to 3\*10\^3/mm\^3,g2:\<3\*10\^3 to 2\*10\^3/mm\^3,g3:\<2\*10\^3 to 1\*10\^3/mm\^3,g4:\<1\*10\^3/mm\^3);hemoglobin(g1:increase in hemoglobin level\>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level\>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level\>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.

ALT/AST(grade\[g\]1:\>ULN-3\*ULN,g2:\>3-5\*ULN,g3:\>5-20\*ULN,g4:\>20\*ULN);AP(g1:\>ULN-2.5\*ULN,g2:\>2.5-5\*ULN,g3:\>5-20\*ULN,g4:\>20\*ULN);CR(g1:\>ULN-1.5\*ULN,g2:\>1.5-3\*ULN,g3:\>3-6\*ULN,g4:\>6\*ULN);hyperglycemia(g1:\>ULN-160mg/dL,g2:\>160-250mg/dL,g3:\>250-500mg/dL,g4:\>500mg/dL);bilirubin(total)(g1:\>ULN-1.5\*ULN,g2:\>1.5-3\*ULN,g3:\>3-10\*ULN,g4:\>10\*ULN);hypoglycemia(g1:\<LLN-55mg/dL,g2:\<55-40mg/dL,g3:\<40-30mg/dL,g4:\<30mg/dL);hyperkalemia(g1:\>ULN-5.5mmol/L,g2:\>5.5-6mmol/L,g3:\>6-7mmol/L,g4:\>7mmol/L);hypokalemia(g1:\<LLN-3mmol/L,g2:\<LLN-3mmol/L,g3:\<3-2.5mmol/L,g4:\<2.5mmol/L);hypermagnesemia(g1:\>ULN-3mg/dL,g3:\>3-8mg/dL,g4:\>8mg/dL);hypocalcemia(g1:\<LLN-8mg/dL,g2:\<8-7mg/dL,g3:\<7-6mg/dL,g4:\<6mg/dL);hypomagnesemia(g1:\<LLN-1.2mg/dL,g2:\<1.2-0.9mg/dL,g3:\<0.9-0.7mg/dL,g4:\<0.7mg/dL);hyponatremia(g1:\<LLN-130mmol/L,g3:\<130-120mmol/L,g4:\<120mmol/L);hypoalbuminemia(g1:\<LLN-3g/dL,g2:\<3-2g/dL,g3:\<2g/dL,g4:lifethreatening);hypophosphatemia(g1:\<LLN-2.5mg/dL,g2:\<2.5-2mg/dL,g3:\<2-1mg/dL,g4:\<1mg/dL).Participant\>=1abnormality given.

Criteria for abnormal value of ECG parameters: maximum increase from baseline (IFB) in QT interval using Fridericia's correction (QTcF)/QT interval using Bazett's correction (QTcB) range from less than (\<)30 millisecond (msec), 30 to \<60, greater than or equal to (\>=)60 msec; maximum post-dose QTcF/QTcB ranges from \<450 msec, 450 to \<480 msec, 480 to \<500, and \>=500 msec; PR interval: \>=50 percent (%) increase when baseline \<200 msec; or increase \>=25% when baseline less than or equal to (\<=)200 msec; QRS interval: \>=50% increase when baseline \<100 msec; \>=25% increase when baseline \>=100 msec. Only categories which included atleast 1 participant with abnormality are reported in this outcome measure.

Fundoscopy examination included an examination of the vitreous body, retina macula, retina non-macula, optic nerve head, optic disc notching and fundus using the category of the examination status (normal, mild, moderate, or severe). In this outcome measure, number of participants with abnormal fundoscopy values identified by investigator were reported.

ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. In case of target lesions CR was defined as the disappearance of all target lesions and in case nodal disease included in the sum of target lesions. The nodes decreased to normal size (\<10 mm). In case of non-target lesions disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed responses were those who persisted on repeat imaging study at least 4 weeks after the initial documentation of response.

DR was defined as the time from date of first documentation of CR or PR to first documentation of objective tumor progression or death due to any cause, whichever occurred first. In case of target lesions CR was defined as the disappearance of all target lesions and in case nodal disease included in the sum of target lesions. The nodes decreased to normal size (\<10 mm). In case of non-target lesions disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Objective tumor progression as per RECIST version 1.1 was defined as \>=20% increase in sum of diameters of target lesions taking as a reference smallest sum of diameters recorded since treatment started, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier method.

Area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.

Rac was defined as the ratio of AUCtau of Cycle 2 Day 1 to AUCtau of Cycle 1 Day 1, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing).

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent oral clearance was obtained by dividing study drug dose with AUCtau, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.

Fraction of unbound Crizotinib concentration in plasma was defined as the ratio of unbound Crizotinib concentration to the total Crizotinib concentration.

Unbound area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration post-dose of Cycle 2 day 1.

Unbound area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.

Area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours postdose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1. AUCtau of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.

AUClast of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.

Cmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.

Tmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.

Metabolite ratio for AUCtau was defined as the ratio of AUCtau of metabolite (PF-06260182) to AUCtau of parent drug (Crizotinib), where AUCtau was the area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.

Metabolite ratio for AUClast was defined as the ratio of AUClast of metabolite (PF-06260182) to AUClast of parent drug (Crizotinib), where AUClast was area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration post-dose of Cycle 1 Day 1.

Metabolite ratio for Cmax was defined as the ratio of Cmax of metabolite (PF-06260182) to Cmax of parent drug (Crizotinib), where Cmax was maximum observed plasma concentration post-dose of Cycle 1 Day 1.

Metabolite ratio for Cmax was defined as the ratio of Cmax of metabolite (PF-06260182) to Cmax of parent drug (Crizotinib), where Cmax was maximum observed plasma concentration post-dose of Cycle 2 Day 1.

Fraction of unbound PF-06260182 (a metabolite of Crizotinib) in plasma was defined as the ratio of unbound PF-06260182 concentration in plasma to the total PF-06260182 concentration.

Unbound AUClast of PF-06260182 (a metabolite of Crizotinib) is reported in this outcome measure.

Unbound area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1. Unbound AUCtau of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.

Unbound Cmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.

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Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Participants with normal hepatic function received Crizotinib 250 milligram (mg) capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and aspartate aminotransferase (AST) levels less than or equal to (\<=) the upper limit of normal (ULN).

Normal Hepatic Function: Crizotinib 250 mg Twice Daily

Participants with normal hepatic function received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles and dose could be increased to 250 mg twice daily after completion of pharmacokinetic (PK) assessment on Cycle 2 Day 1 based on their tolerability. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Normal hepatic function was defined as total bilirubin and AST levels \<=ULN.

Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily

Participants with mild hepatic impairment received Crizotinib 250 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Mild hepatic impairment was defined as total bilirubin level \<=ULN and AST levels greater than (\>) ULN or total bilirubin level \> 1.0 to 1.5\*ULN.

Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily

Participants with moderate hepatic impairment received Crizotinib 200 mg capsules, orally, twice daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level \>1.5 to 3\*ULN

Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily

Participants with moderate hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Moderate hepatic impairment was defined as total bilirubin level \>1.5 to 3\*ULN

Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily

Participants with severe hepatic impairment received Crizotinib 250 mg capsules, orally, once daily continuously in 28-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred. Severe hepatic Impairment was defined as total bilirubin level \>3\*ULN.

Severe Hepatic Impairment Crizotinib 250 mg Once Daily

Total

Age, Continuous

Sex: Female, Male

Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.

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PK evaluable set:Cycle 2 Day 1(C2D1)full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or\>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.

Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1

Confidence interval (CI): Geometric mean ratio and 90 percent (%) CI were derived from analysis of variance (ANOVA) model.

CI: Geometric mean ratio and 90% CI were derived from ANOVA model.

PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or\>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.

Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1

PK evaluable set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 1 Day 1

PK evaluable set. Here, 'N' signifies those participants who were evaluable for this measure.

Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 1 Day 1

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib: Cycle 1 Day 1

Minimum Observed Plasma Concentration (Cmin) of Crizotinib: Cycle 2 Day 1

Data for this outcome measure was not estimated, since few secondary PK parameters listed in the protocol and/or SAP were not estimated, due to change in planned analysis. However, it did not affect the interpretation of the final PK data.

Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 2 Day 1

Plasma Accumulation Ratio (Rac) of Crizotinib

Apparent Oral Clearance (CL/F) of Crizotinib: Cycle 2 Day 1

Fraction of Unbound Crizotinib in Plasma: Cycle 2 Day 1

Unbound Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 2 Day 1

Unbound Area Under Plasma Concentration-Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1

Unbound Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1

Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06260182: Cycle 2 Day 1

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast) of PF-06260182: Cycle 1 Day 1

Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 1 Day 1

Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 2 Day 1

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06260182: Cycle 1 Day 1

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06260182: Cycle 2 Day 1

Metabolite Ratio for Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06260182: Cycle 2 Day 1

Metabolite Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of PF-06260182: Cycle 1 Day 1

Metabolite Ratio for Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 1 Day 1

Metabolite Ratio for Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 2 Day 1

Fraction of Unbound PF-06260182 in Plasma: Cycle 2 Day 1

Unbound Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast) of PF-06260182: Cycle 2 Day 1

Unbound Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06260182: Cycle 2 Day 1

Unbound Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 2 Day 1

Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of Crizotinib: Cycle 2 Day 1

Unbound Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of Crizotinib: Cycle 2 Day 1

Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of PF-06260182: Cycle 2 Day 1

Unbound Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of PF-06260182: Cycle 2 Day 1

SAEs

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Grade 1 AEs

Grade 2 AEs

Grade 3 AEs

Grade 4 AEs

Grade 5 AEs

Number of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade

Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

Anemia: Grade 1

Anemia: Grade 2

Anemia: Grade 3

Hemoglobin Increased: Grade 1

Lymphopenia: Grade 1

Lymphopenia: Grade 2

Lymphopenia: Grade 3

Lymphopenia: Grade 4

Neutrophils (Absolute): Grade 1

Neutrophils (Absolute): Grade 2

Neutrophils (Absolute): Grade 3

Platelets: Grade 1

Platelets: Grade 2

Platelets: Grade 3

White Blood Cells: Grade 1

White Blood Cells: Grade 2

White Blood Cells: Grade 3

Number of Participants With Laboratory Test Abnormalities: NCI CTCAE (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities

Alanine aminotransferase (ALT): Grade 1

ALT: Grade 2

ALT: Grade 3

Alkaline phosphatase(AP): Grade 1

Alkaline phosphatase: Grade 2

Alkaline phosphatase: Grade 3

AST:Grade 1

AST: Grade 2

AST: Grade 3

AST: Grade 4

Bilirubin (total): Grade 1

Bilirubin (total): Grade 2

Bilirubin (total): Grade 3

Bilirubin (total): Grade 4

Creatinine (CR): Grade 1

CR: Grade 2

CR: Grade 3

Hyperglycemia: Grade 1

Hyperglycemia: Grade 2

Hyperglycemia: Grade 3

Hyperkalemia: Grade 1

Hyperkalemia: Grade 2

Hyperkalemia: Grade 3

Hypermagnesemia: Grade 1

Hypoalbuminemia: Grade 1

Hypoalbuminemia: Grade 2

Hypoalbuminemia: Grade 3

Hypocalcemia: Grade 1

Hypocalcemia: Grade 2

Hypoglycemia: Grade 1

Hypokalemia: Grade 1

Hypokalemia: Grade 3

Hypomagnesemia: Grade 1

Hyponatremia: Grade 1

Hyponatremia: Grade 3

Hypophosphatemia: Grade 1

Hypophosphatemia: Grade 2

Hypophosphatemia: Grade 3

Number of Participants With Laboratory Test Abnormalities: NCI CTCAE (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities

Maximum Post-dose QTCF Interval: <450 msec

Maximum Post-dose QTCF Interval: 450 to <480 msec

Maximum Post-dose QTCF Interval: 480 to <500 msec

Maximum Post-dose QTCF Interval: >=500 msec

Maximum Post-dose QTCB Interval: <450 msec

Maximum Post-dose QTCB Interval: 450 to <480 msec

Maximum Post-dose QTCB Interval: 480 to <500 msec

Maximum Post-dose QTCB Interval: >=500 msec

Maximum QTCF Interval IFB: <30 msec

Maximum QTCF Interval IFB: 30 to 60 msec

Maximum QTCF IFB: >=60 msec

Maximum QTCB Interval IFB: <30 msec

Maximum QTCB Interval IFB: 30 to 60 msec

Maximum QTCB Interval IFB: >=60 msec

Maximum PR Interval IFB: >=50%

Maximum PR Interval IFB, Other Than: >=25 or 50%

Maximum QRS Interval IFB, Other Than: >=25 or 50%

Number of Participants With Abnormal Electrocardiogram (ECG) Findings

Right Eye, Retina Macula: Mild Abnormality

Right Eye, Retina Non-Macula: Mild Abnormality

Right Eye, Optic Disc Notching: Mild Abnormality

Right Eye, Fundus: Mild Abnormality

Right Eye, Vitreous Body: Mild Abnormality

Left Eye, Retina Non-Macula: Mild Abnormality

Left Eye, Vitreous Body: Mild Abnormality

Left Eye, Fundus: Mild Abnormality

Left Eye, Retina Macula: Mild Abnormality

Left Eye, Optic Disc Notching: Mild Abnormality

Number of Participants With Abnormal Fundoscopy Examination Findings

Response-evaluable population was defined as all participants in the safety analysis population who had an adequate baseline tumor assessment.

Objective Response Rate (ORR)

Response evaluable population. Here, 'N' signifies participants who were evaluable for this outcome measure. Data for normal hepatic function (200 mg), moderate (250 mg) and severe (250 mg) hepatic impairment arms was not estimable since no participants had achieved CR or PR in these reporting arms.

Spots Global Cancer Trial Database for Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients

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