Last updated: 11/03/2018 10:29:52
Monotherapy Pazopanib in Subjects with Advanced Non-Small Cell Lung Cancer
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects with Advanced Non-Small Cell Lung Cancer
Trial description: This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage of participants who achieved either a confirmed complete response or partial response per RECIST criteria
Timeframe: Baseline through End of Study (up to 2 years)
Secondary outcomes:
Number of participants who had a complete or partial response, or stable disease
Timeframe: Baseline through End of Study (up to 2 years)
Progression-Free Survival
Timeframe: Baseline through End of Study (up to 2 years)
Overall Survival
Timeframe: Baseline through End of Study (up to 2 years)
Levels of circulating biomarkers in plasma
Timeframe: Baseline through End of Study (up to 2 years)
Characterization of participant populations by identification of intra-tumoral biomarkers
Timeframe: Baseline through End of Study (up to 2 years)
Interventions:
Drug: Pazopanib (GW786034)
Enrollment:
14
Observational study model:
Not applicable
Primary completion date:
2009-20-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
February 2008 to April 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Signed consent
- Histologically- or cytologically confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer.
- Prior malignancy - unless disease-free for at least 3 years, or have had completely resected non-melanomatous skin cancer or successfully treated in situ carcinoma.
- History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, except for subjects with previously-treated CNS metastases, who are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
Inclusion and exclusion criteria
Inclusion criteria:
- Signed consent
- Histologically- or cytologically confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer.
- Failed no more than two prior chemotherapy regimens for Stage IIIB or IV non-small cell lung cancer, including a platinum-containing regimen.
- Brain metastases permitted if subject has been treated with surgery and/or radiation therapy more than 4 weeks prior to date of first dose and is stable for at least one week off steroids.
- 18 years of age or older.
- Eastern Cooperative Oncology Group performance status of at least 2.
- Measurable disease according to RECIST.
- Adequate organ system function.
- Females may be eligible to enroll if they are of non-childbearing potential (surgically sterile or post-menopausal)or are using appropriate contraception methods.
Exclusion criteria:
- Prior malignancy
- unless disease-free for at least 3 years, or have had completely resected non-melanomatous skin cancer or successfully treated in situ carcinoma.
- History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, except for subjects with previously-treated CNS metastases, who are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
- Clinically significant gastrointestinal abnormalities.
- Presence of uncontrolled infection.
- Corrected QT interval greater than 480 msec.
- History of significant cardiovascular condition(s).
- Poorly controlled hypertension (systolic blood pressure of 140mmHG or greater or diastolic blood pressure of 90mmHg or greater).
- History of cerebrovascular accident, pulmonary embolism, or insufficiently treated deep venous thrombosis within the past 6 months prior to first dose of study drug.
- Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- Active bleeding or diathesis.
- Hemoptysis in excess of 2.5mL within 8 weeks of first dose of study drug.
- Serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures.
- Use of prohibited medications as defined in protocol.
- Use of an investigational agent, including an investigational anti-cancer agent within 28 days, or 5 half-lives, whichever is longer, prior to first dose of study drug.
- Prior use of any investigational or licensed anti-angiogenic agent, including thalidomide and agents that target platelet-derived growth factor. Prior treatment with bevacizumab or epidermal growth factor receptor tyrosine kinase inhibitors
Trial location(s)
Location
GSK Investigational Site
Duluth, Minnesota, United States, 55805
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23601
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
Status
Study Complete
Location
GSK Investigational Site
Fort Myers, Florida, United States, 33916
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85258
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14263
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sayre, Pennsylvania, United States, 18840
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78463-3069
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70809
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2009-20-04
Actual study completion date
2009-20-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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