NCT01262820

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 16, 2016

Completed
Last Updated

March 7, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

December 7, 2010

Results QC Date

July 28, 2016

Last Update Submit

January 23, 2017

Conditions

Lung Cancer

Keywords

PazopanibNon Squamous Non Small Cell Lung CancerAfter Progress on first line therapyUsing Bevacizumab

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1

    8 months with additional time for response to mature (up to 2 years per participant)

  • Progression Free Survival

    Eight (8) months w additional time for response data to mature (up to 2 years per participant)

  • Overall Survival

    Eight (8) months w additional time for response date to mature (up to 2 years per participant)

Study Arms (1)

Single Intervention

EXPERIMENTAL

Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study

Drug: Pazopanib

Interventions

PazopanibDRUG

Pazopanib, 800 mg by mouth daily each 21 day cycle

Single Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Carolina Cancer Hospital at U of North Carolina at CH

Chapel Hill, North Carolina, 27599, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Robin V. Johnson
Organization
UNC Lineberger Comprehensive Cancer Center
Robin_V_Johnson@med.unc.edu
919-966-1125

Study Officials

  • Thomas Stinchcombe, MD

    North Carolina Cancer Hospital at University of NC at Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 17, 2010

Study Start

December 1, 2010

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

March 7, 2017

Results First Posted

September 16, 2016

Record last verified: 2017-01

Locations

US(2)