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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

Phase 1
18 Years
Not Enrolling
Lung Cancer, Non-Small Cell

Thank you

Trial Information

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

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: safety and tolerability (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status)

Outcome Time Frame:

at least one cycle of treatment (3 weeks)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

July 2009

Completion Date:

October 2012

Related Keywords:

  • Lung Cancer, Non-Small Cell
  • paclitaxel
  • pazopanib
  • Advanced Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • Advanced Solid Tumor
  • GW786034
  • Metastatic Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SitePark Ridge, Illinois  60068