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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status) [ Time Frame: at least one cycle of treatment (3 weeks) ] [ 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 [ Time Frame: Cycle 1 and Cycle 2 PK sampling ] [ Designated as safety issue: No ]
Phase I: clinical activity [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
Phase II: overall survival [ Time Frame: Up to apoprox 12 months after last subject is randomised ] [ Designated as safety issue: No ]
Phase II: best overall response [ Time Frame: Up to apoprox 12 months after last subject is randomised ] [ Designated as safety issue: No ]
Phase II: safety and tolerability (Serious adverse events, adverse events, clinical laboratory data, vital signs, ECG, ECOG performance status) [ Time Frame: Up to apoprox 12 months after last subject is randomised ] [ 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
Experimental: Phase II Arm 1 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	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
Active Comparator: Phase II Arm 2 paclitaxel IV 225 mg/m2 and carboplatin IV AUC 6 mg/mL.min once every 3 weeks	Drug: paclitaxel + carboplatin paclitaxel IV 225 mg/m2 and carboplatin IV AUC 6 mg/mL.min once every 3 weeks
Experimental: Phase I oral pazopanib once daily (Phase I starting dose 800 mg) and paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).	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

Locations

United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43210
United Kingdom
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
GSK Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00866528 History of Changes
Other Study ID Numbers:	111109
Study First Received:	March 19, 2009
Last Updated:	December 21, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

paclitaxel
NSCLC
pazopanib

non-small cell lung cancer
carboplatin
GW786034

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012