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

Primary Purpose

Lung Cancer, Non-Small Cell

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
pazopanib
paclitaxel
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer, Non-Small Cell focused on measuring paclitaxel, NSCLC, pazopanib, Advanced Non-Small Cell Lung Cancer, non-small cell lung cancer, Advanced Solid Tumor, GW786034, Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase I

Arm Description

oral pazopanib once daily (Phase I starting dose 800 mg) and paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).

Outcomes

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)

Secondary Outcome Measures

Phase I: paclitaxel and pazopanib pharmacokinetics
Phase I: clinical activity

Full Information

First Posted
March 19, 2009
Last Updated
November 8, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00866528
Brief Title
Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 9, 2009 (Actual)
Primary Completion Date
October 25, 2012 (Actual)
Study Completion Date
October 25, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
pazopanib
Other Intervention Name(s)
Votrient
Intervention Description
oral pazopanib once daily (Phase I starting dose 800 mg)
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2).
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Phase I: paclitaxel and pazopanib pharmacokinetics
Time Frame
Cycle 1 and Cycle 2 PK sampling
Title
Phase I: clinical activity
Time Frame
at least 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
GSK Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

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

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