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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002190-33 | EudraCT Number |
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See termination reason in detailed description.
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To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.
The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and venous thrombotic events (VTEs) were reported in patients treated in Part I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | PF-04856884 in combination with AG-013736 |
|
| ARM B | Active Comparator | AG-013736 alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04856884 | Biological | 15 mg/kg/week intravenously [IV] until toxicity or disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall). | Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). | 4 months |
| Number of Participants With Serious Adverse Events (SAEs) in Part I | Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE. | 4 months |
| Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II | PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date - the date of randomization +1). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious AEs and SAEs | Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
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Inclusion Criteria:
Exclusion Criteria:
Part I:
Part II:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Oncology Hematology | Scottsdale | Arizona | 85258 | United States | ||
| Arizona Oncology Associates, PC - HOPE |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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During Part I, 3 to 4 participants were initially treated with the study drug combination in 28-day cycles. If no participants experienced Cycle 1 dose limiting toxicities (DLTs), another 6 to 9 participants were treated at this dose level. Part II of the study was to be initiated if Cycle 1 DLTs were observed in <33% in at least 12 participants.
This multicenter, open-label study consisted of a safety lead in stage (Part I) followed by a randomized Phase 2 stage (Part II). A total of 18 participants were screened and assigned to treatment in Part I, with 3 participants completing Part I of the study. At the completion of Part I, all 18 participants had discontinued combined treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04856884 + AG-013736 | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
Not provided
Not provided
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Not provided
| Axitinib (AG-013736) | Drug | 5 mg PO BID |
|
| Axitinib (AG-013736) | Drug | 5 mg PO BID |
|
| 3 years |
| Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone. | ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR. | 4 months |
| Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone | DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR - first CR or PR that is subsequently confirmed +1). | 3 years |
| Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached) | Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods. | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
| Cmax (Observed Peak Serum PF-04856884 Concentration) | Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods. | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
| Cmin (Trough PF-04856884 Serum Concentration) | Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods. | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
| Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive | Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884. | 0 and 360 hours post dose and end of study |
| Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment | PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date - the date of randomization +1). | 3 years |
| Overall Survival (OS) at 2 Years | OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS. | 5 years |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Arizona Oncology Associates, PC-HOPE | Tucson | Arizona | 85710 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers | Centennial | Colorado | 80112 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80909 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80220 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers | Littleton | Colorado | 80120-4413 | United States |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers | Longmont | Colorado | 80501 | United States |
| Rocky Mountain Cancer Centers | Parker | Colorado | 80138 | United States |
| Rocky Mountain Cancer Centers | Pueblo | Colorado | 81008 | United States |
| Rocky Mountain Cancer Centers | Thornton | Colorado | 80260 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89014 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Regional Cancer Care-Durham | Durham | North Carolina | 27704 | United States |
| Texas Oncology-Tyler | Tyler | Texas | 75702 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Masarykuv onkologicky ustav | Brno | 65653 | Czechia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis (FA) set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-04856884 + AG-013736 | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). |
| 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 Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall). | Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). | The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. | Posted | Number | participants | 4 months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) in Part I | Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE. | The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. | Posted | Number | participants | 4 months |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II | PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date - the date of randomization +1). | The primary efficacy endpoint of estimating median PFS in Part II was not assessed due to early termination of the study. | Posted | 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Non-serious AEs and SAEs | Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). | This endpoint was not assessed due to the early termination of the study. | Posted | 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone. | ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR. | The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. | Posted | Number | Percentage of participants | 4 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone | DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR - first CR or PR that is subsequently confirmed +1). | This endpoint was not assessed due to the early termination of the study. | Posted | 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached) | Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods. | The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. | Posted | Mean | Standard Deviation | hr | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax (Observed Peak Serum PF-04856884 Concentration) | Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods. | The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmin (Trough PF-04856884 Serum Concentration) | Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods. | The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive | Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884. | The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics. | Posted | Number | ADA samples | 0 and 360 hours post dose and end of study | ADA samples | ADA samples |
|
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment | PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date - the date of randomization +1). | This endpoint of estimating median PFS was not assessed due to early termination of the study. | Posted | 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at 2 Years | OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS. | This endpoint was not assessed due to the early termination of the study. | Posted | 5 years |
|
|
From the day the first dose of the investigational product was administered up to 1 year.
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 participant and as nonserious in another participant, or one participant 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-04856884 + AG-013736 | Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). | 12 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Haptoglobin increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Neutrophil count abnormal | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| White blood cell count abnormal | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Flat affect | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
|
On 06 Nov 2012, based on Part I safety findings and due to strategic considerations, Pfizer decided not to open enrolment onto Part II of the study and terminated the study. For primary OM, AEs reported in ≥2 participants overall are presented.
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 |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| OG007 | Treatment-related Overall | Incidence and severity of treatment-related CTCAE Grades 3,4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Leukocytosis |
|
| Pericardial effusion |
|
| Hyperthyroidism |
|
| Hypothyroidism |
|
| Vision blurred |
|
| Abdominal pain |
|
| Constipation |
|
| Diarrhoea |
|
| Dry mouth |
|
| Gastritis |
|
| Nausea |
|
| Oral pain |
|
| Stomatitis |
|
| Toothache |
|
| Vomiting |
|
| Asthenia |
|
| Fatigue |
|
| Oedema peripheral |
|
| Pneumonia |
|
| Upper respiratory tract infection |
|
| Urinary tract infection |
|
| Blood creatinine increased |
|
| Weight decreased |
|
| Decreased appetite |
|
| Dehydration |
|
| Hypercalcaemia |
|
| Hypokalaemia |
|
| Hyponatraemia |
|
| Hypovolaemia |
|
| Arthralgia |
|
| Back pain |
|
| Muscle spasms |
|
| Muscular weakness |
|
| Myalgia |
|
| Cerebrovascular accident |
|
| Dizziness |
|
| Headache |
|
| Migraine |
|
| Neuropathy peripheral |
|
| Depression |
|
| Insomnia |
|
| Proteinuria |
|
| Cough |
|
| Dysphonia |
|
| Dyspnoea |
|
| Hypoxia |
|
| Pleural effusion |
|
| Pulmonary embolism |
|
| Night sweats |
|
| Palmar-plantar erythrodysaesthesia |
|
| Hot flush |
|
| Hypertension |
|
| Hypotension |
|
Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 4 TEAEs are presented |
| OG003 | All-causality CTCAE Grade 5 | Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 5 TEAEs are presented |
|
|
| Participants |
|
|
|
|
|
| ADA samples |
|
|