Trial Outcomes & Findings for Pazopanib As Pre-Surgical Therapy In Treatment-Naive Subjects With Non-Small Cell Lung Cancer (NCT NCT00367679)

Last Updated: 2012-06-12

Results Overview

Tumor shrinkage was assessed as the change in tumor volume using high-resolution computed tomography scans of the thorax following treatment with pazopanib. Response is defined as the number of participants achieving at least 50% tumor volume reduction following pazopanib treatment. "Responder" is a participant whose tumor volume reduced at least 50% following pazopanib treatment. "Non-responder" is a participant whose tumor volume did not reduce at least 50% following treatment. Tumor assessments were conducted by a central reviewer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Baseline to at least two weeks or at most six weeks

Results posted on

2012-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Pazopanib 800 mg Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib As Pre-Surgical Therapy In Treatment-Naive Subjects With Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib 800 mg n=35 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Age Continuous	63.7 years STANDARD_DEVIATION 8.84 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized White	28 participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to at least two weeks or at most six weeks

Population: Safety Population: all participants who received at least one dose of pazopanib

Outcome measures

Outcome measures
Measure	Pazopanib 800 mg n=35 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume Responder	2 participants
Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume Non-responder	33 participants

SECONDARY outcome

Timeframe: Baseline to at least two weeks or at most six weeks

Population: Safety population: all participants who received at least one dose of pazopanib

Response is the number of participants achieving either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a \>=20% increase in target lesions; Stable Disease, small changes not meeting previously given criteria. Confirmation requires at least 2 assessments (conducted by a central reviewer) of CR/PR with at least 4 weeks between the assessments.

Outcome measures

Outcome measures
Measure	Pazopanib 800 mg n=35 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Number of Participants Achieving a Clinical Response Based on RECIST Complete response	0 participants
Number of Participants Achieving a Clinical Response Based on RECIST Partial response	3 participants
Number of Participants Achieving a Clinical Response Based on RECIST Stable disease	31 participants
Number of Participants Achieving a Clinical Response Based on RECIST Progressive disease	1 participants

SECONDARY outcome

Timeframe: Baseline to at least two weeks or at most six weeks

Population: Safety Population: all participants who received at least one dose of pazopanib

Response is the number of participants whose tumor demonstrated a 60% or greater reduction in metabolic activity (SUV) as measured by positron emission tomography (PET) or PET/computed tomography (PET/CT) at the end of treatment visit relative to baseline. This analysis was not conducted because insufficient data were collected: only three participants had PET/CT data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to at least three weeks and at most 8 weeks

Population: Safety Population

Shifts in hematology values by grade were summarized based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (Version 3.0 - definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here.

Outcome measures

Outcome measures
Measure	Pazopanib 800 mg n=35 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values Lymphocytes, Grade 2 (<0.8-0.5 x 10^9/L)	5 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values Lymphocytes, Grade 3 (<0.5-0.2 x 10^9/L)	1 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values Neutrophils, Grade 2 (<1.5-1.0 x 10^9/L)	4 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values Neutrophils, Grade 3 (<1.0-0.5 x 10^9/L)	1 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values White blood cells, Grade 2 (<3.0-2.0 x 10^9/L)	3 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values White blood cells, Grade 3 ( <2.0-1.0 x 10^9/L)	0 participants

SECONDARY outcome

Timeframe: Baseline to at least three weeks and at most 8 weeks

Population: Safety Population

Shifts in chemistry values by grade were summarized based on the NIH Common Terminology Criteria for Adverse Events (Version 3.0 - definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here. ULN = upper limit of normal; Gr = grade; mg = milligrams; dL = deciliter; mmol = millimoles.

Outcome measures

Outcome measures
Measure	Pazopanib 800 mg n=35 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Hyperglycemia, Grade 2 (>160-250 mg/dL)	4 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Hyperkalemia, Grade 3 (>6.0-7.0 mmol/L)	1 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Alkaline phosphatase, Grade 2 (>2.5-5.0 x ULN)	2 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Alanine aminotransferase, Grade 2 (>2.5-5.0 ULN)	6 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Alanine aminotransferase, Gr 3 (>5.0-20.0 x ULN)	2 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Aspartate aminotransferase, Gr 2 (>2.5-5.0 x ULN)	3 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Aspartate aminotransferase, Gr 3 (>5.0-20.0 x ULN)	1 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Total bilirubin, Grade 3 (>3.0-10.0 x ULN)	1 participants
Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values Hypocalcemia, Grade 4 (<6.0 mg/dL)	1 participants

SECONDARY outcome

Timeframe: Baseline to at least three weeks and at most 8 weeks

Population: Safety Population

Increases in systolic or diastolic blood pressure values at any point in the study following baseline were summarized. mmHg = millimeters of mercury. Baseline blood pressure values as well as the change from baseline experienced are given in the category titles.

Outcome measures

Outcome measures
Measure	Pazopanib 800 mg n=35 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Number of Participants With the Indicated Change From Baseline in Systolic and Diastolic Blood Pressure Diastolic, BL: 50-89 mmHg; up to 90-109 mmHg	4 participants
Number of Participants With the Indicated Change From Baseline in Systolic and Diastolic Blood Pressure Systolic, BL: 90-139 mmHg; up to 140-169 mmHg	12 participants

SECONDARY outcome

Timeframe: Baseline to at least three weeks and at most 8 weeks (surgery date)

Population: Tissue from Safety Population: all participants who received at least one dose of pazopanib

Tumor cells from pre-treatment and post-operative biopsies were to have been analyzed to determine the number of cells that were exhibiting apoptosis. Due to the limited quantity of tissue in pre- and post-treatment biopsy samples, these assays were not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to at least three weeks and at most 8 weeks (surgery date)

Population: Tumor tissue from Safety Population: all participants who received at least one dose of pazopanib. Only 26 of 35 subjects had sufficient tissue in both pre- and post-treatment samples for analysis.

Gene expression data analysis was performed with GeneSpring GX 7.3.1 (Agilent Technologies). Data were preprocessed using the RMA algorithm. The Benjamini and Hochberg false discovery rate was used for multiple testing corrections. Data below are log-transformed ratios of the post-treatment to pre-treatment expression intensity, indicating the fold increase/decrease in expression of genes. PDGF, platelet-derived growth factor; VEGFR, vascular endothelial growth factor receptor; c-KIT, a protein tyrosine kinase that is a receptor for stem cell factor or "kit" ligand.

Outcome measures

Outcome measures
Measure	Pazopanib 800 mg n=26 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes Thrombospondin 1	3.234 ratio Standard Deviation 1.56
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes PDGF-alpha	10.350 ratio Standard Deviation 2.433
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes PDGF-beta	4.075 ratio Standard Deviation 1.504
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes VEGF A	-1.129 ratio Standard Deviation 0.852
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes VEGF C	3.232 ratio Standard Deviation 1.547
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes VEGF D	3.569 ratio Standard Deviation 2.537
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes VEGFR-1	4.258 ratio Standard Deviation 1.792
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes VEGFR-2	1.943 ratio Standard Deviation 1.572
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes KIT	1.394 ratio Standard Deviation 1.621
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes Angiopoietin 1	4.901 ratio Standard Deviation 2.066
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes Angiopoietin 2	4.207 ratio Standard Deviation 1.587
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes Transforming growth factor 3	3.054 ratio Standard Deviation 1.280
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes Fibroblast growth factor 7	3.679 ratio Standard Deviation 1.310

SECONDARY outcome

Timeframe: Baseline to at least three weeks and at most 8 weeks (surgery date)

Population: Safety Population: all participants who received at least one dose of pazopanib

Specific genes (KRAS, MYC, TP53, and others) were to have been analyzed for the presence or absence of amplifications or deletions and for the presence, absence, and sequence of point mutations in pre- or post-treatment tumor biopsies. These analyses were not conducted because the potential results were considered to provide overlapping information with those obtained in the transcriptional and proteomic profiling assays that were conducted. The clinical study report indicates that genetic measures were to have been reported separately.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline tumor biopsy

Population: Safety Population: all participants who received at least one dose of pazopanib

A pre-treatment tumor biopsy from each participant was to have been analyzed by Western blotting to semi-quantitate levels of various proteins related to angiogenesis and/or to the mechanism of action of pazopanib. These assays were not carried out due to insufficient quantity of tissue present in the pre-treatment biopsy (fine needle aspirate). The clinical study report indicates that results were to have been reported separately.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to at least three weeks and at most 8 weeks

Population: Safety Population: all participants who received at least one dose of pazopanib

LDH5 has been shown to be associated with activation of angiogenesis in lung cancer. Circulating levels of LDH5 were to have been measured at each scheduled visit through the post-treatment visit to determine if a correlation with drug effect existed. Levels of LDH5 were measured, but the team determined that greater value was to be derived from transcriptional and plasma biomarker analyses; thus, no analyses were conducted to examine the correlation of LDH5 levels with effects of pazopanib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Safety Population: all participants who received at least one dose of pazopanib

Plasma samples were collected from each consenting participant, generally at baseline, to permit evaluation of the presence or absence of genetic variations in select candidate genes in germline DNA. Analyses that could have been done might have examined the relationship between genetic variants and the safety or tolerability or the efficacy of pazopanib. Analyses have not yet been conducted, but a need to do so may yet be identified. The clinical study report indicated that results, if any, would be reported separately.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Entire study interval

Population: Safety Population: all participants who received at least one dose of pazopanib

Analysis not performed as part of study. Appropriate material was not available for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to at least two weeks and at most 6 weeks

Population: Safety population: all participants who received at least one dose of pazopanib. Only 33 of 35 subjects had plasma samples from both pre- and post-treatment available for analysis.

Baseline and post-therapy plasma samples were obtained from participants. Immunohistochemistry analyses were carried out using a BioPlex 200 machine (Bio-Rad) or by enzyme-linked immunoassays to evaluate levels of angiogenesis-related proteins and other relevant proteins. Post- and pre-treatment changes in cytokines and angiogenic factors in response to pazopanib were analyzed. A negative value indicates that the post-treatment level of the particular target protein was less than the pre-treatment level.

Outcome measures

Outcome measures
Measure	Pazopanib 800 mg n=33 Participants Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Vascular endothelial growth factor receptor	-1.35 ratio Interval -1.644 to -1.155
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Placental growth factor	18.04 ratio Interval 8.374 to 69.273
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Interferon inducible cytokine	1.60 ratio Interval 1.046 to 2.794
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Cutaneous T-cell attracting chemokine	1.12 ratio Interval -1.04 to 1.311
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Stromal cell-derived factor 1	1.08 ratio Interval -1.013 to 1.1
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Monokine induced by interferon gamma	1.33 ratio Interval -1.001 to 2.358
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Tumor necrosis factor ligand	1.05 ratio Interval 1.007 to 1.118
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Interferon alpha 2	1.04 ratio Interval -1.006 to 1.079
Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins Vascular endothelial growth factor	-1.01 ratio Interval -1.362 to 2.307

Adverse Events

Pazopanib 800 mg

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pazopanib 800 mg n=35 participants at risk Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Vascular disorders Hypertension	2.9% 1/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Respiratory, thoracic and mediastinal disorders Chylothorax	2.9% 1/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Infections and infestations Pneumonia	2.9% 1/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Psychiatric disorders Anxiety	2.9% 1/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.9% 1/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.

Other adverse events

Other adverse events
Measure	Pazopanib 800 mg n=35 participants at risk Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
Vascular disorders Hypertension	40.0% 14/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Gastrointestinal disorders Diarrhea	37.1% 13/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
General disorders Fatigue	37.1% 13/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Gastrointestinal disorders Nausea	34.3% 12/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Investigations Alanine Aminotransferase increased	22.9% 8/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Nervous system disorders Headache	22.9% 8/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Investigations Aspartate aminotransferase increased	17.1% 6/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Skin and subcutaneous tissue disorders Hair color changes	14.3% 5/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Psychiatric disorders Insomnia	11.4% 4/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Gastrointestinal disorders Vomiting	11.4% 4/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Respiratory, thoracic and mediastinal disorders Cough	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
General disorders Asthenia	8.6% 3/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Psychiatric disorders Anxiety	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Musculoskeletal and connective tissue disorders Muscle spasms	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Nervous system disorders Peripheral sensory neuropathy	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Skin and subcutaneous tissue disorders Alopecia	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Skin and subcutaneous tissue disorders Erythema	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Skin and subcutaneous tissue disorders Rash	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Respiratory, thoracic and mediastinal disorders Hypoventilation	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Investigations Blood alkaline phosphatase increased	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Investigations Blood thyroid stimulating hormone increased	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Metabolism and nutrition disorders Anorexia	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Musculoskeletal and connective tissue disorders Procedural pain	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.
Infections and infestations Urinary tract infection	5.7% 2/35 • All AEs and SAEs were to be collected and recorded from receipt of first dose of pazopanib until 28 days following cessation of pazopanib, regardless of initiation of new cancer therapy.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER