An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma

NCT ID: NCT00597116

Last Updated: 2016-10-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-01-31

Brief Summary

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A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.

Detailed Description

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Conditions

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Mesothelioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Vinorelbine

Group Type ACTIVE_COMPARATOR

Vinorelbine

Intervention Type DRUG

2

Vandetanib

Group Type EXPERIMENTAL

Vandetanib

Intervention Type DRUG

once daily oral dose

Interventions

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Vinorelbine

Intervention Type DRUG

Vandetanib

once daily oral dose

Intervention Type DRUG

Other Intervention Names

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Navelbine® ZD6474 ZACTIMA™

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with mesothelioma
* Previously treated with only one course of chemotherapy for mesothelioma
* No previous treatment with vinorelbine
* No serious heart problems within the last 3 months

Exclusion Criteria

* Serious abnormal laboratory values
* Severe or uncontrolled disease or condition as judged by the Investigator
* Pregnant or breast-feeding women
* Other cancers within the last 5 years
* Major surgery or radiation therapy within 4 weeks prior to starting study therapy
* Receipt of any investigational agents within 30 days prior to commencing study treatment.
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

Locations

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Research Site

Essen, , Germany

Site Status

Research Site

Halle-Dolau, , Germany

Site Status

Research Site

Hamburg, , Germany

Site Status

Research Site

Heidelberg, , Germany

Site Status

Research Site

Chur, , Switzerland

Site Status

Research Site

Zurich, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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EUDRACT Number 2007-003633-16

Identifier Type: -

Identifier Source: secondary_id

D4200C00075

Identifier Type: -

Identifier Source: org_study_id

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