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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866528
First received: March 19, 2009
Last updated: September 13, 2012
Last verified: August 2012
History of Changes

March 19, 2009
September 13, 2012
July 2009
April 2012   (final data collection date for primary outcome measure)
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 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 ]
Complete list of historical versions of study NCT00866528 on ClinicalTrials.gov Archive Site
  • 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 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 ]
 
 
 
Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer
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

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.
 
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer, Non-Small Cell
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).
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).
Intervention: Drug: pazopanib + paclitaxel
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00866528
111109
No
GlaxoSmithKline
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP