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Trial record 30 of 727 for:    Area Under Curve AND Bioavailability

A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01168934
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : October 19, 2011
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Healthy
Intervention Drug: crizotinib
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV
Hide Arm/Group Description Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period. Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.
Period Title: First Intervention Period
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Washout Period (at Least 14 Days)
Started 7 7
Completed 7 7
Not Completed 0 0
Period Title: Second Intervention Period
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
35.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
0
   0.0%
Male
14
 100.0%
1.Primary Outcome
Title Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞][dn])
Hide Description AUC [0 - ∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - ∞) divided by dose.
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL/mg
21.36  (3.99) 9.28  (3.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib 50 mg IV, Crizotinib 250 mg Oral
Comments Natural log transformed AUC (0 - ∞)(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means
Estimated Value 43.44
Confidence Interval (2-Sided) 90%
39.68 to 47.56
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])
Hide Description AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1067.00  (198.54) 2321.00  (833.14)
3.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1007.00  (182.84) 2250.00  (821.30)
4.Secondary Outcome
Title Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn])
Hide Description AUClast[dn] = Dose normalized area under the plasma concentration time-curve (AUC[dn]) from zero to the last measured concentration.
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL/mg
20.14  (3.63) 9.00  (3.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Crizotinib 50 mg IV, Crizotinib 250 mg Oral
Comments Natural log transformed AUClast(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of adjusted geometric means
Estimated Value 44.67
Confidence Interval (2-Sided) 90%
40.90 to 48.78
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
155.00  (29.57) 99.60  (28.82)
6.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: hr
5.0
(4.0 to 6.0)
7.Secondary Outcome
Title Plasma Decay Half Life (t1/2)
Hide Description Plasma decay half life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: hr
38.86  (6.10) 28.98  (2.96)
8.Secondary Outcome
Title Apparent Oral Clearance (CL/F)
Hide Description Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Time Frame 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14
Geometric Mean (Standard Deviation)
Unit of Measure: L/hr
107.7  (36.1)
9.Secondary Outcome
Title Systemic Clearance (CL)
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Overall Number of Participants Analyzed 14
Geometric Mean (Standard Deviation)
Unit of Measure: L/hr
46.83  (8.64)
10.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F)
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time Frame 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14
Geometric Mean (Standard Deviation)
Unit of Measure: L
4478.0  (1665.3)
11.Secondary Outcome
Title Volume of Distribution at Steady State (Vss)
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Overall Number of Participants Analyzed 14
Geometric Mean (Standard Deviation)
Unit of Measure: L
1772.00  (328.75)
12.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)
Hide Description Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
35.61  (17.64) 342.70  (116.22)
13.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)
Hide Description AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).
Time Frame 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
Arm/Group Title Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
360.4  (117.2)
14.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
3.01  (1.46) 26.46  (6.41)
15.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: hr
5.00
(5.00 to 6.07)
16.Secondary Outcome
Title Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)
Hide Description Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: Ratio
0.034  (0.011) 0.148  (0.021)
17.Secondary Outcome
Title Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time (MRAUC [0-∞])
Hide Description Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) (MRAUC [0-∞]).
Time Frame 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
Arm/Group Title Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: Ratio
0.144  (0.019)
18.Secondary Outcome
Title Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)
Hide Description Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).
Time Frame 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description:
Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
Overall Number of Participants Analyzed 14 14
Geometric Mean (Standard Deviation)
Unit of Measure: Ratio
0.019  (0.007) 0.258  (0.043)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Crizotinib 50 mg IV Crizotinib 250 mg Oral
Hide Arm/Group Description Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period. Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
All-Cause Mortality
Crizotinib 50 mg IV Crizotinib 250 mg Oral
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Crizotinib 50 mg IV Crizotinib 250 mg Oral
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Crizotinib 50 mg IV Crizotinib 250 mg Oral
Affected / at Risk (%) Affected / at Risk (%)
Total   8/14 (57.14%)   5/14 (35.71%) 
Gastrointestinal disorders     
Diarrhoea * 1  2/14 (14.29%)  4/14 (28.57%) 
Flatulence * 1  1/14 (7.14%)  1/14 (7.14%) 
General disorders     
Catheter site pain * 1  2/14 (14.29%)  0/14 (0.00%) 
Catheter site phlebitis * 1  1/14 (7.14%)  0/14 (0.00%) 
Influenza like illness * 1  1/14 (7.14%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/14 (7.14%)  0/14 (0.00%) 
Nervous system disorders     
Paraesthesia * 1  1/14 (7.14%)  1/14 (7.14%) 
Somnolence * 1  1/14 (7.14%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea * 1  1/14 (7.14%)  1/14 (7.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01168934     History of Changes
Other Study ID Numbers: A8081010
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: September 12, 2011
Results First Posted: October 19, 2011
Last Update Posted: October 24, 2011