NCT00496275

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

First QC Date

July 3, 2007

Last Update Submit

August 25, 2016

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLCZACTIMA

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered

    Predetermined timepoints after dose administration

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

Interventions

Zactima (ZD6474)DRUG
Vinorelbine plus cisplatinDRUG
Gemcitabine plus cisplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vandetanibVinorelbineCisplatinGemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 4, 2007

Study Start

August 1, 2006

Study Completion

May 1, 2007

Last Updated

August 26, 2016

Record last verified: 2016-08