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

NCT ID: NCT00496275

Last Updated: 2016-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zactima (ZD6474)

Intervention Type DRUG

Vinorelbine plus cisplatin

Intervention Type DRUG

Gemcitabine plus cisplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

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D4200C00054

Identifier Type: -

Identifier Source: org_study_id

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