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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best overall response and progression free survival

Outcome Description:

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

Outcome Time Frame:

Eight (8) months w additional time for response date to mature

Safety Issue:

Yes

Principal Investigator

Thomas Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Carolina Cancer Hospital at University of NC at Chapel Hill

Authority:

United States: Food and Drug Administration

Study ID:

LCCC0921

NCT ID:

NCT01262820

Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Lung Cancer
  • Pazopanib
  • Non Squamous Non Small Cell Lung Cancer
  • After Progress on first line therapy
  • Using Bevacizumab
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Rex Cancer Center at Rex HospitalRaleigh, North Carolina  27607
North Carolina Cancer Hospital at U of North Carolina at CHChapel Hill, North Carolina  27599