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

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT00496275
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study Completion: 2007-05
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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