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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00866528

Purpose

The main purpose of this study (in Phase II) is to determine whether the combination of pazopanib and paclitaxel is safe and effective in the treatment of advanced NSCLC. In order to make this determination, the Phase I part of the study must first identify the doses of pazopanib and paclitaxel that can be administered safely in combination.

Condition	Intervention	Phase
Advanced Non-Small Cell Lung Cancer Advanced Solid Tumor Metastatic Non-Small Cell Lung Cancer	Drug: pazopanib + paclitaxel Drug: paclitaxel + carboplatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-label, Multicenter, Phase I/II Study of Pazopanib in Combination With Paclitaxel in First-line Treatment of Subjects With Stage IIIBwet/IV Non-small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Pazopanib

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Phase I: safety and tolerability [ Designated as safety issue: Yes ]
Phase II: Progression-free survival [ Time Frame: At least 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phase I: paclitaxel and pazopanib pharmacokinetics [ Designated as safety issue: No ]
Phase I: clinical activity [ Designated as safety issue: No ]
Phase II: overall survival [ Designated as safety issue: No ]
Phase II: best overall response [ Designated as safety issue: No ]
Phase II: safety and tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase II Arm 2: Active Comparator	Drug: paclitaxel + carboplatin paclitaxel IV 225 mg/m2 and carboplatin IV AUC 6 mg/mL.min once every 3 weeks
Phase I: Experimental	Drug: pazopanib + paclitaxel oral pazopanib once daily (Phase I starting dose 800 mg) and paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2). Phase II doses will be determined by Phase I
Phase II Arm 1: Experimental	Drug: pazopanib + paclitaxel oral pazopanib once daily (Phase I starting dose 800 mg) and paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2). Phase II doses will be determined by Phase I

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866528

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

United States, Ohio
GSK Investigational Site	Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Miguel Villalona

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111109, VEG111109
Study First Received:	March 19, 2009
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00866528 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW786034
pazopanib
paclitaxel
carboplatin
NSCLC

Study placed in the following topic categories:

Thoracic Neoplasms
Carboplatin
Antimitotic Agents
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel

Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 25, 2009