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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.
This is a Phase II, multicenter, prospective, open label, single arm study. The primary endpoint of the study is progression-free rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 at week 12 after start of treatment. The secondary endpoints include overall progression-free survival (PFS), response rate (RR), duration of response, overall survival (OS), and toxicity assessment through the reporting of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pazopanib | Experimental | Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pazopanib | Drug | Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-week Progression Free Rate | Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion. | Assessed after 12 weeks of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian L Samuels, MD | Northwest Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States | ||
| Washington Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pazopanib | Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Date of Consent until progression or death, up to 27 months |
| Best Overall Response | Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Date of consent until end of study treatment, up to 32 months |
| Duration of Response | Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met. | Measure of the amount of time that the criteria for response per RECIST are first met until disease progression |
| Overall Survival (OS) | OS was measured from date of consent until time of death from any cause, up to 32 months. | Date of Consent until death, up to 32 months |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | United States |
| Oncology Specialists, SC | Niles | Illinois | 60714 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Pennsylvania Oncology Hematology Associates | Philadelphia | Pennsylvania | 19106 | United States |
| West Clinic | Memphis | Tennessee | 38120 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pazopanib | Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. |
| 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 |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | 12-week Progression Free Rate | Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion. | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed after 12 weeks of study treatment |
|
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months. | Posted | Median | 95% Confidence Interval | months | Date of Consent until progression or death, up to 27 months |
|
| |||||||||||||||||||||||||||
| Secondary | Best Overall Response | Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Posted | Number | percentage of participants | Date of consent until end of study treatment, up to 32 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Duration of Response | Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met. | Since so few patients experienced a response, the pre-specified endpoint of duration of response was not analyzed. | Posted | Measure of the amount of time that the criteria for response per RECIST are first met until disease progression |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was measured from date of consent until time of death from any cause, up to 32 months. | Posted | Median | 95% Confidence Interval | months | Date of Consent until death, up to 32 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pazopanib | Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity. | 17 | 41 | 39 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Gastric Perforation | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| death | General disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Hepatic Haemorrhage | Hepatobiliary disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Escherichia Sepsis | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Perirectal Abscess | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 4.0 | Non-systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | CTCAE 4.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Depressed Level Of Consciousness | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Mental Disorder Due To A General Medical Condition | Psychiatric disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Exfoliation Syndrome | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Exophthalmos | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Eye Swelling | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Scleral Disorder | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Colonic Fistula | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Gastrointestinal Fistula | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Gastrointestinal Motility Disorder | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Impaired Gastric Emptying | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Large Intestinal Ulcer Haemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Asthenia | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Early Satiety | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Localised Oedema | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Peripheral Swelling | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Temperature Intolerance | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Nail Infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Stress Fracture | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Transfusion Reaction | Injury, poisoning and procedural complications | CTCAE 4.0 | Systematic Assessment |
| |
| Activated Partial Thromboplastin Time Prolonged | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Blood Culture Positive | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Gastrointestinal Infection | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Lipase Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Prothrombin Time Prolonged | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Troponin I Increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Urine Output Decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Urine Protein/Creatinine Ratio | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Iron Deficiency | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Salivary Gland Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Disturbance In Attention | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Metabolic Encephalopathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vocal Cord Paralysis | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Testicular Swelling | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Vaginal Haemorrhage*f | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment | *f: Adverse Event was female specified, and percentage was based on female population(Nf=14). |
|
| Vulvovaginal Dryness*f | Reproductive system and breast disorders | CTCAE 4.0 | Systematic Assessment | *f: Adverse Event was female specified, and percentage was based on female population(Nf=14). |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Granulomatous Dermatitis | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Non-systematic Assessment |
| |
| Hair Colour Changes | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nail Discolouration | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rash Papular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin Exfoliation*m | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment | *m: Adverse Event was male specified, and percentage was based on male population(Nm=27). |
|
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin Mass | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin Necrosis | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Stasis Dermatitis | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
|
Institution/PI may use Institution/PI derived Study results in a Publication provided Publication does not disclose Vector Confidential Information unnecessary to publish Study results. Institution/PI will submit to Vector for review/comment proposed Publication and data necessary for meaningful review at least 30 days prior to submission. Vector may request delay of submission up to 60 days in order to file patent applications relating to an Invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Walker, VP of Scientific Affairs | Vector Oncology LLC | 901-435-5570 | mwalker@vectoroncology.com |
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
Not provided
Not provided
| ID | Term |
|---|---|
| C516667 | pazopanib |
Not provided
Not provided
Not provided
|
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