Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer

NCT00549328 | Terminated Phase 2 Results

• 1 other identifier: 109609
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 13

Brief Summary

This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.

Conditions

Lung Cancer, Non-Small Cell

Keywords

anti-angiogenesis; Non-small cell lung cancer,; pazopanib (GW786034)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria

  The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.

  Baseline through End of Study (up to 2 years)

Secondary Outcomes (5)

• Number of Participants Who Had a Complete or Partial Response, or Stable Disease

  Baseline through End of Study (up to 2 years)

• Progression-Free Survival

  Baseline through End of Study (up to 2 years)

• Overall Survival

  Baseline through End of Study (up to 2 years)

• Levels of Circulating Biomarkers in Plasma

  Baseline through End of Study (up to 2 years)

• Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers

  Baseline through End of Study (up to 2 years)

Study Arms (1)

Pazopanib Open-label

EXPERIMENTAL

Single-arm, non-randomised, single-stage pazopanib monotherapy.

Drug: Pazopanib (GW786034)

Interventions

Pazopanib (GW786034) DRUG

Pazopanib monotherapy

Pazopanib Open-label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent
• Histologically- or cytologically confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer.
• Failed no more than two prior chemotherapy regimens for Stage IIIB or IV non-small cell lung cancer, including a platinum-containing regimen.
• Brain metastases permitted if subject has been treated with surgery and/or radiation therapy more than 4 weeks prior to date of first dose and is stable for at least one week off steroids.
• years of age or older.
• Eastern Cooperative Oncology Group performance status of at least 2.
• Measurable disease according to RECIST.
• Adequate organ system function.
• Females may be eligible to enroll if they are of non-childbearing potential (surgically sterile or post-menopausal)or are using appropriate contraception methods.

You may not qualify if:

• Prior malignancy - unless disease-free for at least 3 years, or have had completely resected non-melanomatous skin cancer or successfully treated in situ carcinoma.
• History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, except for subjects with previously-treated CNS metastases, who are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
• Clinically significant gastrointestinal abnormalities.
• Presence of uncontrolled infection.
• Corrected QT interval greater than 480 msec.
• History of significant cardiovascular condition(s).
• Poorly controlled hypertension (systolic blood pressure of 140mmHG or greater or diastolic blood pressure of 90mmHg or greater).
• History of cerebrovascular accident, pulmonary embolism, or insufficiently treated deep venous thrombosis within the past 6 months prior to first dose of study drug.
• Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
• Active bleeding or diathesis.
• Hemoptysis in excess of 2.5mL within 8 weeks of first dose of study drug.
• Serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures.
• Use of prohibited medications as defined in protocol.
• Use of an investigational agent, including an investigational anti-cancer agent within 28 days, or 5 half-lives, whichever is longer, prior to first dose of study drug.
• Prior use of any investigational or licensed anti-angiogenic agent, including thalidomide and agents that target platelet-derived growth factor. Prior treatment with bevacizumab or epidermal growth factor receptor tyrosine kinase inhibitors

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Scottsdale, Arizona, 85258, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33916, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70809, United States

Location

GSK Investigational Site

Duluth, Minnesota, 55805, United States

Location

GSK Investigational Site

Buffalo, New York, 14263, United States

Location

GSK Investigational Site

Columbus, Ohio, 43219, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19106, United States

Location

GSK Investigational Site

Sayre, Pennsylvania, 18840, United States

Location

GSK Investigational Site

Corpus Christi, Texas, 78463-3069, United States

Location

GSK Investigational Site

Newport News, Virginia, 23601, United States

Location

GSK Investigational Site

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 25, 2007
• Study Start: February 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 19, 2014
• Results First Posted: January 27, 2010

Record last verified: 2014-11

Locations

US (13)