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

NCT ID: NCT00866528

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-09
• Study Completion Date: 2012-10-25

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 Protocol Amendment 01.

Conditions

Lung Cancer, Non-Small Cell

Keywords

paclitaxel; NSCLC; pazopanib; Advanced Non-Small Cell Lung Cancer; non-small cell lung cancer; Advanced Solid Tumor; GW786034; Metastatic Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

pazopanib

Intervention Type: DRUG

oral pazopanib once daily (Phase I starting dose 800 mg)

paclitaxel

Intervention Type: DRUG

paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).

Interventions

pazopanib

oral pazopanib once daily (Phase I starting dose 800 mg)

Intervention Type: DRUG

paclitaxel

paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).

Intervention Type: DRUG

Other Intervention Names

Votrient

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Sutton, Surrey, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

111109

Identifier Type: -

Identifier Source: org_study_id