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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00367679 |
This is a phase 2 open-label, non-randomized study to evaluate the safety and efficacy of pazopanib as pre-surgical treatment for patients with stage 1A or 1B Non Small Cell Lung Cancer (NSCLC).
Condition | Intervention | Phase |
---|---|---|
Non-Small-Cell Lung Cancer |
Drug: Pazopanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Non-Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Pazopanib (GW786034) as Pre-Surgical Therapy in Treatment-Naive Subjects With Stage IA or IB, Resectable Non Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 33 |
Study Start Date: | November 2006 |
Study Completion Date: | April 2008 |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
System (Laboratory Values) Hematologic:Absolute neutrophil count (ANC)(≥ 1.5 X 109/L)Hemoglobin (≥9 g/dL)Platelets(≥100 X 109/L) Hepatic:Albumin (≥ 2.5 g/dL)Serum bilirubin(≤1.5 X upper limit of normal (ULN) unless due to Gilbert's syndrome) AST and ALT(≤2.0 X ULN) Renal:Serum creatinine(≤1.5 mg/dL)OR Calculated creatinine clearance(≥30 mL/min)Urine Protein1 (Tace or +1 by dipstick urinalysis or <1.0 gram determined by 24-hour urine protein analysis.)
Ability to swallow and retain oral medication
Exclusion criteria:
Poorly controlled hypertension (mean systolic blood pressure (SBP) of ≥140mmHg, or mean diastolic blood pressure (DBP) of ≥ 90mmHg. Note: Initiation or adjustment of anti-hypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 5 minutes. The mean SBP/DBP values from both BP assessments must be < 140/90mmHg in order for a subject to be eligible for the study.
United States, California | |
GSK Investigational Site | |
Duarte, California, United States, 91010 | |
GSK Investigational Site | |
Rancho Mirage, California, United States, 92270 | |
United States, Colorado | |
GSK Investigational Site | |
Aurora, Colorado, United States, 80045 | |
United States, Delaware | |
GSK Investigational Site | |
Newark, Delaware, United States, 19718 | |
United States, Florida | |
GSK Investigational Site | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60612 | |
United States, New Jersey | |
GSK Investigational Site | |
Paramus, New Jersey, United States, 07652 | |
United States, New York | |
GSK Investigational Site | |
Flushing, New York, United States, 11355 | |
GSK Investigational Site | |
New York, New York, United States, 10016 | |
GSK Investigational Site | |
New York, New York, United States, 10021 | |
Israel | |
GSK Investigational Site | |
Jerusalem, Israel, 91120 | |
Spain | |
GSK Investigational Site | |
Pamplona, Spain, 31008 | |
GSK Investigational Site | |
Barcelona, Spain, 08035 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VEG105290 |
Study First Received: | August 22, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00367679 |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
I-ELCAP non-small cell lung cancer NSCLC |
pazopanib GW786034 antiangiogenesis |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |