Status:
COMPLETED
Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Non-Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be administered safely in combination. The Phase II part of the study will not be progressed as documented in...
Eligibility Criteria
Inclusion
- Written informed consent
- At least 18 years old
- Histologically- or cytologically-confirmed diagnosis of Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC (or for Phase I only, advanced solid tumor for which there is no standard therapy or for whom paclitaxel is standard therapy).
- No prior systemic first-line therapy for advanced disease
- Measurable disease
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks.
- Able to swallow and retain oral medication
- Adequate organ system function (hematological, renal, and hepatic)
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception
Exclusion
- Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC (or for Phase I, other than the primary solid tumor)
- CNS metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
- Clinically significant gastrointestinal abnormalities
- Prolongation of corrected QT interval (QTc) \> 480 msecs
- History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- Poorly controlled hypertension
- History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
- Evidence of active bleeding or bleeding diathesis
- Recent hemoptysis
- Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
- Use of any prohibited medication
- Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
- Ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity except alopecia
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, paclitaxel, and/or carboplatin.
Key Trial Info
Start Date :
July 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00866528
Start Date
July 9 2009
End Date
October 25 2012
Last Update
November 13 2017
Active Locations (4)
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1
GSK Investigational Site
Chicago, Illinois, United States, 60637
2
GSK Investigational Site
Columbus, Ohio, United States, 43210
3
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
4
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN