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Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab (LCCC0921)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01262820
First received: December 7, 2010
Last updated: October 30, 2014
Last verified: October 2014

December 7, 2010
October 30, 2014
December 2010
September 2014   (final data collection date for primary outcome measure)
Best overall response and progression free survival [ Time Frame: Eight (8) months w additional time for response date to mature ] [ Designated as safety issue: Yes ]
CR + PR + SD equal to or greater than 12 weeks that will evalute the activity of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who have progressed on first line therapy containing bevacizumab
Same as current
Complete list of historical versions of study NCT01262820 on ClinicalTrials.gov Archive Site
Estimate combined response rate CR + PF of pazopanib according to RECIST [ Time Frame: 8 months with additional time for response to mature ] [ Designated as safety issue: No ]
To estimate the progression free survival (time of enrollment until disease progression or death) and overall survival from time of enrollment to death. To evaluate the safety and tolerability of pazopanib using the NCI CTCAE version 4.0 To explore potential correlations betweel blood biomarkers and clinical response
Same as current
Not Provided
Not Provided
 
Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab
A Multi-Center Open Label Phase II Study of Pazopanib in Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer After Progression on First Line Therapy Containing Bevacizumab

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: Pazopanib
Pazopanib, 800 mg by mouth daily each 21 day cycle
Experimental: Single Intervention
Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study
Intervention: Drug: Pazopanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 or older
  • Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph node involvement) or stage IV NSCLC
  • Evidence of progression while on bevacizumab
  • Patients treated for CNS metastases who are asymptomatic with no requirement for steroids for 2 weeks prior to first dose of study drug

Exclusion Criteria:

  • Prior malignancy
  • Clinically significant gastrointestinal abnormalities
  • Presence of uncontrolled infection or nonhealing wound, fracture, or ulcer
  • History of cardiovascular conditions within the past 6 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01262820
LCCC0921
Yes
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
GlaxoSmithKline
Principal Investigator: Thomas Stinchcombe, MD North Carolina Cancer Hospital at University of NC at Chapel Hill
UNC Lineberger Comprehensive Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP