Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Lung Cancer, Non-Small Cell

Treatments

Drug: paclitaxel

Drug: pazopanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866528

111109

Details and patient eligibility

About

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 Protocol Amendment 01.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.