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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Cohort 5 | Experimental |
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| Cohort 6 | Experimental |
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| Cohort 7 | Experimental |
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| Cohort 8 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00337210 | Drug | 0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) | DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting. | Baseline up to Day 28 |
| Maximum Tolerated Dose (MTD) | MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting. | Day 28 |
| Maximum Administered Dose (MAD) | MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 | |
| Plasma Decay Half-Life (t1/2) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Food on Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | Pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 29 (fasted state), Day 30 (fed state) for once daily groups, pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 29 Day 29 (fasted state), Day 30 (fed state) for twice daily groups |
Inclusion Criteria:
During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Detroit | Michigan | 48201 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-00337210 0.67 mg Once Daily | PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days. |
| FG001 | PF-00337210 1 mg Once Daily | PF-00337210 1 mg capsule orally once daily in cycles of 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cohort 9 | Experimental |
|
| Cohort 10 | Experimental |
|
| PF-00337210 |
| Drug |
1mg Capsule Once Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 2mg Capsule Once Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 4mg Capsule Once Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 6mg Capsule Once Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 9mg Capsule Once Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 8mg Capsule Once Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 4mg Capsule Twice Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 6mg Capsule Twice Daily (Dose Escalation) Continuous |
|
| PF-00337210 | Drug | 6mg Capsule Twice Daily (Dose Expansion) Continuous |
|
| Day 28 |
| Recommended Phase-2 Dose (RP2D) | RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing. | Day 28 |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 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 - ∞). | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
| Apparent Volume of Distribution (Vss) | 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 is influenced by the fraction absorbed. | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
| Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
| Number of Participants With Objective Response of Complete Response or Partial Response | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions and no appearance of new lesions. Confirmed PR defined as at least 30 percent decrease in sum of the longest dimensions (LD) of the target lesions, taking as a reference the baseline sum LD, without progression of non-target lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. | Baseline, every 8 weeks up to Cycle 25 (Week 100) |
| Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25 | Biomarkers included soluble plasma proteins associated with angiogenesis (vascular endothelial growth factor [VEGF], soluble vascular endothelial growth factor-2 receptor [sVEGFR2], soluble vascular endothelial growth factor-3 receptor [sVEGFR3], soluble beta type platelet-derived growth factor [sPDGFR beta]) and tumor proliferation (soluble stem-cell factor receptor [sKIT]) | Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53792 | United States |
| FG002 | PF-00337210 2 mg Once Daily | PF-00337210 2 mg capsule orally once daily in cycles of 28 days. |
| FG003 | PF-00337210 4 mg Once Daily | PF-00337210 4 mg capsule orally once daily in cycles of 28 days. |
| FG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| FG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| FG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| FG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| FG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-00337210 | PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Baseline up to Day 28 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) | MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | Number | mg once daily | Day 28 |
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| Primary | Maximum Administered Dose (MAD) | MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | Number | mg once daily | Day 28 |
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| Primary | Recommended Phase-2 Dose (RP2D) | RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | Number | mg twice daily | Day 28 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) | Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Cmax was not calculated. | Posted | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
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| Secondary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, t1/2 was not calculated. | Posted | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0-24) was not calculated. | Posted | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 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 - ∞). | Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0 - ∞) was not calculated. | Posted | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
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| Secondary | Apparent Volume of Distribution (Vss) | 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 is influenced by the fraction absorbed. | Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Vss was not calculated. | Posted | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
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| Secondary | Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Formal quality-assured, quality-controlled, PK analysis was not performed and hence, CL was not calculated. | Posted | Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57 |
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| Secondary | Number of Participants With Objective Response of Complete Response or Partial Response | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions and no appearance of new lesions. Confirmed PR defined as at least 30 percent decrease in sum of the longest dimensions (LD) of the target lesions, taking as a reference the baseline sum LD, without progression of non-target lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. | Full Analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline, every 8 weeks up to Cycle 25 (Week 100) |
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| Secondary | Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25 | Biomarkers included soluble plasma proteins associated with angiogenesis (vascular endothelial growth factor [VEGF], soluble vascular endothelial growth factor-2 receptor [sVEGFR2], soluble vascular endothelial growth factor-3 receptor [sVEGFR3], soluble beta type platelet-derived growth factor [sPDGFR beta]) and tumor proliferation (soluble stem-cell factor receptor [sKIT]) | Results are not reported as the data were not statistically summarized but available in individual participant listing. | Posted | Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 |
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| Other Pre-specified | Effect of Food on Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] | AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). | Formal quality-assured, quality-controlled, PK analysis was not performed and hence, food effect on AUC (0-24) was not assessed. | Posted | Pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 29 (fasted state), Day 30 (fed state) for once daily groups, pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 29 Day 29 (fasted state), Day 30 (fed state) for twice daily groups |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-00337210 | PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days. | 19 | 46 | 46 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tongue exfoliation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Induration | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Multiple allergies | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Band neutrophil count increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Carbon dioxide decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| White blood cell count | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Joint warmth | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nodule on extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin neoplasm bleeding | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urogenital haemorrhage | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Breast discomfort | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Designation of outcomes as primary and secondary was based on study team input as study did not specify primary or secondary outcome measures.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C562231 | PF 00337210 |
Not provided
Not provided
Not provided
| PF-00337210 6 mg Twice Daily |
PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
|
|
|
|
| PF-00337210 6 mg Once Daily |
PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
| OG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
| OG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
PF-00337210 4 mg capsule orally once daily in cycles of 28 days. |
| OG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
PF-00337210 4 mg capsule orally once daily in cycles of 28 days. |
| OG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
| OG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
|
PF-00337210 4 mg capsule orally once daily in cycles of 28 days. |
| OG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|
PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
| OG004 | PF-00337210 6 mg Once Daily | PF-00337210 6 mg capsule orally once daily in cycles of 28 days. |
| OG005 | PF-00337210 8 mg Once Daily | PF-00337210 8 mg capsule orally once daily in cycles of 28 days. |
| OG006 | PF-00337210 9 mg Once Daily | PF-00337210 9 mg capsule orally once daily in cycles of 28 days. |
| OG007 | PF-00337210 4 mg Twice Daily | PF-00337210 4 mg capsule orally twice daily in cycles of 28 days. |
| OG008 | PF-00337210 6 mg Twice Daily | PF-00337210 6 mg capsule orally twice daily in cycles of 28 days. |
|