search
Back to results

Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Zactima (ZD6474)
Vinorelbine plus cisplatin
Gemcitabine plus cisplatin
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, ZACTIMA

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed non small cell lung cancer (stage IIIB-IV)
  • Life expectancy greater than 12 weeks
  • At least 1 measurable lesion greater than 10mm in smallest diameter.

Exclusion Criteria:

  • Prior treatment with anticancer agent
  • Brain metastases
  • Major surgery within last 4 weeks

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

    Secondary Outcome Measures

    Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered
    Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

    Full Information

    First Posted
    July 3, 2007
    Last Updated
    August 25, 2016
    Sponsor
    Genzyme, a Sanofi Company
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00496275
    Brief Title
    Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC
    Official Title
    A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genzyme, a Sanofi Company

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Small Cell Lung Cancer
    Keywords
    NSCLC, ZACTIMA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Zactima (ZD6474)
    Intervention Type
    Drug
    Intervention Name(s)
    Vinorelbine plus cisplatin
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine plus cisplatin
    Primary Outcome Measure Information:
    Title
    Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered
    Time Frame
    Predetermined timepoints after dose administration
    Title
    Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed non small cell lung cancer (stage IIIB-IV) Life expectancy greater than 12 weeks At least 1 measurable lesion greater than 10mm in smallest diameter. Exclusion Criteria: Prior treatment with anticancer agent Brain metastases Major surgery within last 4 weeks
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Sciences & Operations
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

    We'll reach out to this number within 24 hrs