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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is an open label Phase II Trial that using the investigational anti-cancer agent, Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by decreasing the size of the tumor or stopping its growth.
This multi-centered phase II trial will examine pazopanib stage IIIB/IV non-squamous NSCLC patients who have progressed on first-line therapy containing bevacizumab. Treatment should continue until disease progression, unacceptable toxicity, study withdrawal, or death. Patients who progress will be treated at the discretion of their physician. all patients who initiate treatment will be evaluated for disease control rate, which is the primary endpoint of this study.
The primary objective is to estimate the disease control rate of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who progressed while on bevacizumab. Disease control rate id defined as complete (CR) + partial response (PR) + stable disease (SD) lasting greater than or equal to 12 weeks as defined by RECIST.
Secondary Objectives To estimate the combined response rate (CR + PR) of pazopanib according to RECIST To estimate the progression free survival (defined as time of enrollment until disease progression or death) and overall survival (defined as time of enrollment until death) of patients treated with pazopanib.
To evaluate the safety and tolerability of pazopanib using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0 To explore potential correlations between blood biomarkers and clinical response.
Pazopanib is dosed continuously throughout the study. Cycle lengths are identified as 21 days for purposes of the calendar.
The treatment dosage and administration for participating subjects will be, Pazopanib, 800 mg by mouth daily during a 21 day cycle until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Intervention | Experimental | Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pazopanib | Drug | Pazopanib, 800 mg by mouth daily each 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Response (CR + PR + SD) as defined by RECIST v1.1 lasting equal to or greater than 12 weeks in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as Disappearance of all target lesions; Partial Response (PR), as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions; Progression, as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Target lesions are representative of all involved organs and measurable by radiographic imaging. | Eight (8) months w additional time for response date to mature (up to 2 years per participant) |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1 | Estimate of combined response rate (Complete Response (CR) + Partial Response (PR) per RECIST v1.1 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions.Target lesions are representative of all involved organs and measurable by radiographic imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Stinchcombe, MD | North Carolina Cancer Hospital at University of NC at Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Cancer Hospital at U of North Carolina at CH | Chapel Hill | North Carolina | 27599 | United States | ||
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| Label | URL |
|---|---|
| web address for Lineberger Comprehensive Cancer Center at UNC | View source |
| web address for the National Cancer Institute (NCI) | View source |
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A total of 22 patients provided informed consent for this trial; 7 patients were considered ineligible leaving 15 patients who enrolled and were treated on study.
Subjects were recruited between April 2010 and January 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Intervention | Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Intervention | Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Disease Control Rate | Response (CR + PR + SD) as defined by RECIST v1.1 lasting equal to or greater than 12 weeks in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as Disappearance of all target lesions; Partial Response (PR), as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions; Progression, as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Target lesions are representative of all involved organs and measurable by radiographic imaging. | Posted | Number | 95% Confidence Interval | % of participants with disease control | Eight (8) months w additional time for response date to mature (up to 2 years per participant) |
|
4 years
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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 | Single Intervention | Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin V. Johnson | UNC Lineberger Comprehensive Cancer Center | 919-966-1125 | Robin_V_Johnson@med.unc.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
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| 8 months with additional time for response to mature (up to 2 years per participant) |
| Progression Free Survival | Progression free survival is defined as time of enrollment until disease progression or death Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Progression is defined as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Target lesions are representative of all involved organs and measurable by radiographic imaging. | Eight (8) months w additional time for response data to mature (up to 2 years per participant) |
| Overall Survival | Overall survival is defined as the time of enrollment until death | Eight (8) months w additional time for response date to mature (up to 2 years per participant) |
| University of Pittsburgh Medical Center |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Single Intervention | Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle |
|
|
| Secondary | Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1 | Estimate of combined response rate (Complete Response (CR) + Partial Response (PR) per RECIST v1.1 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions.Target lesions are representative of all involved organs and measurable by radiographic imaging. | Posted | Number | participants | 8 months with additional time for response to mature (up to 2 years per participant) |
|
|
|
| Secondary | Progression Free Survival | Progression free survival is defined as time of enrollment until disease progression or death Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Progression is defined as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Target lesions are representative of all involved organs and measurable by radiographic imaging. | Posted | Median | 95% Confidence Interval | weeks | Eight (8) months w additional time for response data to mature (up to 2 years per participant) |
|
|
|
| Secondary | Overall Survival | Overall survival is defined as the time of enrollment until death | Posted | Median | 95% Confidence Interval | weeks | Eight (8) months w additional time for response date to mature (up to 2 years per participant) |
|
|
|
| 5 |
| 15 |
| 13 |
| 15 |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lung Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pericardial Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | due to lung cancer |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | due to metastatic disease |
|
| intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | bile duct obstruction |
|
| Alanine Aminotransferase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Esophageal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ggt Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hemoglobin Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hepatitis viral | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hot Flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lipase Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lung Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Mucositis Oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oral Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet Count Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pruitus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal And Urinary Disorders - Other, Specify | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Dyduria |
|
| Skin And Subcutaneous Tissue Disorders - Other, Specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Hair color changes (white at scalp) |
|
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight Loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |