ZD6474(Vandetanib) + Alimta Combo Study

NCT ID: NCT00506051

Last Updated: 2016-08-25

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-10-31

Brief Summary

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The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.

Detailed Description

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Conditions

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Carcinoma Non-Small Cell Lung Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZD6474 (vandetanib) 100mg

Group Type EXPERIMENTAL

ZD6474 (vandetanib) 100mg

Intervention Type DRUG

once daily oral tablet

pemetrexed

Intervention Type DRUG

intravenous infusion

ZD6474 (vandetanib) 300mg

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

intravenous infusion

ZD6474 (vandetanib) 300mg

Intervention Type DRUG

Interventions

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ZD6474 (vandetanib) 100mg

once daily oral tablet

Intervention Type DRUG

pemetrexed

intravenous infusion

Intervention Type DRUG

ZD6474 (vandetanib) 300mg

Intervention Type DRUG

Other Intervention Names

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ZACTIMA™ Alimta® ZACTIMA™

Eligibility Criteria

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Inclusion Criteria

* Confirmed advanced or metastatic non-small cell lung cancer
* Failure of first-line chemotherapy
* 1 or more measurable lesion by RECIST

Exclusion Criteria

* Previous chemotherapy or radiotherapy within 4 weeks
* Significant cardiac events, arrythmias or other cardiac conditions
* Unacceptable laboratory measurements
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

References

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de Boer R, Humblet Y, Wolf J, Nogova L, Ruffert K, Milenkova T, Smith R, Godwood A, Vansteenkiste J. An open-label study of vandetanib with pemetrexed in patients with previously treated non-small-cell lung cancer. Ann Oncol. 2009 Mar;20(3):486-91. doi: 10.1093/annonc/mdn674. Epub 2008 Dec 16.

Reference Type BACKGROUND
PMID: 19088171 (View on PubMed)

Other Identifiers

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D4200C00041

Identifier Type: -

Identifier Source: org_study_id

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