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
18 Years
N/A
Both
Advanced Non-Small Cell Lung Cancer, Lung Cancer, Non-Small Cell
Trial Information
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
Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in
subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or
two prior regimens of systemic therapy. The study will be conducted at a limited number of
institutions in the US. A total of 40 evaluable subjects will be enrolled and treated.
Pazopanib will be given at a dose of 800mg (as determined by previous Phase I studies)
orally once per day. Subjects may continue to receive study drug for up to two years unless
they experience disease progression or withdraw from treatment for other reasons, or unless
the Sponsor terminates the study. A rollover study may be available to those subjects who
are exhibiting clinical benefit (stable disease or better). Evaluable subjects will be
assessed for response as the primary endpoint.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria
Outcome Description:
The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.
Outcome Time Frame:
Baseline through End of Study (up to 2 years)
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
109609
NCT ID:
NCT00549328
Start Date:
February 2008
Completion Date:
April 2009
Related Keywords:
- Advanced Non-Small Cell Lung Cancer
- Lung Cancer, Non-Small Cell
- pazopanib (GW786034)
- anti-angiogenesis
- Non-small cell lung cancer,
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | New Orleans, Louisiana 70112 |
| GSK Investigational Site | Duluth, Minnesota 55805 |
| GSK Investigational Site | Akron, Ohio 44304 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Oklahoma City, Oklahoma 73112 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Salem, Virginia 24153 |
| GSK Investigational Site | New York, New York 10021 |
