An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

NCT ID: NCT00410761

Last Updated: 2025-09-24

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-23

Study Completion Date

2024-07-26

Brief Summary

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The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo vandetanib

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Vandetanib

Group Type EXPERIMENTAL

ZD6474 (Vandetanib)

Intervention Type DRUG

once daily oral tablet

Interventions

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ZD6474 (Vandetanib)

once daily oral tablet

Intervention Type DRUG

Other Intervention Names

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ZACTIMA™ SAR390530

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.
* Presence of measurable tumor
* Able to swallow medication

Exclusion Criteria

* Major surgery within 4 weeks before randomization
* Last dose of prior chemotherapy received less than 4 weeks prior to randomization
* Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)
* Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
* Significant cardiac events
* Previous ZD6474 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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Investigational Site Number 3

Little Rock, Arkansas, United States

Site Status

University Arkansas Site Number : 3

Little Rock, Arkansas, United States

Site Status

Investigational Site Number 8

San Francisco, California, United States

Site Status

USCF / Mt Zion Medical Center Site Number : 8

San Francisco, California, United States

Site Status

Investigational Site Number 9

Aurora, Colorado, United States

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University Of Colorado Health Sciences Center Site Number : 9

Aurora, Colorado, United States

Site Status

Investigational Site Number 11

New Haven, Connecticut, United States

Site Status

Yale University School Medicine Site Number : 11

New Haven, Connecticut, United States

Site Status

Investigational Site Number 15

Jacksonville, Florida, United States

Site Status

Mayo Clinic- Site Number : 15

Jacksonville, Florida, United States

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Investigational Site Number 18

Chicago, Illinois, United States

Site Status

The University Of Chicago Site Number : 18

Chicago, Illinois, United States

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Investigational Site Number 17

Lexington, Kentucky, United States

Site Status

The University Of Kentucky Site Number : 17

Lexington, Kentucky, United States

Site Status

Dana Farber Cancer Institute Site Number : 2

Boston, Massachusetts, United States

Site Status

Investigational Site Number 2

Boston, Massachusetts, United States

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Investigational Site Number 7

Detroit, Michigan, United States

Site Status

Wayne State University / Harper Hospital Site Number : 7

Detroit, Michigan, United States

Site Status

Investigational Site Number 14

Rochester, Minnesota, United States

Site Status

Mayo Clinic- Site Number : 14

Rochester, Minnesota, United States

Site Status

Investigational Site Number 10

St Louis, Missouri, United States

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Washington University School Of Med Site Number : 10

St Louis, Missouri, United States

Site Status

Investigational Site Number 6

Cincinnati, Ohio, United States

Site Status

University Of Cincinnati Site Number : 6

Cincinnati, Ohio, United States

Site Status

Investigational Site Number 22

Portland, Oregon, United States

Site Status

Oregon Health & Science University- Site Number : 22

Portland, Oregon, United States

Site Status

Investigational Site Number 19

Charleston, South Carolina, United States

Site Status

Medical University of South Carolina- Site Number : 19

Charleston, South Carolina, United States

Site Status

Anderson Cancer Center Site Number : 13

Houston, Texas, United States

Site Status

Investigational Site Number 13

Houston, Texas, United States

Site Status

Fletcher Allen Health Care Site Number : 21

Burlington, Vermont, United States

Site Status

Investigational Site Number 21

Burlington, Vermont, United States

Site Status

Investigational Site Number 1001

St Leonards, , Australia

Site Status

Investigational Site Number 1901

Vienna, , Austria

Site Status

Investigational Site Number : 1901

Vienna, , Austria

Site Status

Investigational Site Number : 1101

Anderlecht, , Belgium

Site Status

Investigational Site Number 1101

Brussels, , Belgium

Site Status

Investigational Site Number 1102

Leuven, , Belgium

Site Status

Investigational Site Number : 1102

Leuven, , Belgium

Site Status

Hospital De Clinicas De Porto Alegre- Site Number : 2301

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Faculdade de Medicina de Ribeirao Preto - USP- Site Number : 2302

Ribeirão Preto, São Paulo, Brazil

Site Status

Investigational Site Number 2301

Porto Alegre, , Brazil

Site Status

Investigational Site Number 2302

Ribeirão Preto, , Brazil

Site Status

Investigational Site Number : 1203

Calgary, Alberta, Canada

Site Status

Investigational Site Number : 1201

Moncton, New Brunswick, Canada

Site Status

Investigational Site Number : 1202

London, Ontario, Canada

Site Status

Investigational Site Number : 1205

Toronto, Ontario, Canada

Site Status

Investigational Site Number : 1204

Sherbrooke, Quebec, Canada

Site Status

Investigational Site Number 1203

Calgary, , Canada

Site Status

Investigational Site Number 1202

London, , Canada

Site Status

Investigational Site Number 1201

Moncton, , Canada

Site Status

Investigational Site Number 1204

Sherbrooke, , Canada

Site Status

Investigational Site Number 1205

Toronto, , Canada

Site Status

Investigational Site Number 3601

Prague, , Czechia

Site Status

Investigational Site Number : 3601

Prague, , Czechia

Site Status

Investigational Site Number 2701

Odense C, , Denmark

Site Status

Investigational Site Number : 2701

Odense C, , Denmark

Site Status

Investigational Site Number 2802

Bordeaux, , France

Site Status

Investigational Site Number : 2802

Bordeaux, , France

Site Status

Investigational Site Number 2803

Lyon, , France

Site Status

Investigational Site Number : 2803

Lyon, , France

Site Status

Investigational Site Number 2801

Villejuif, , France

Site Status

Investigational Site Number : 2801

Villejuif, , France

Site Status

Investigational Site Number 2002

Essen, , Germany

Site Status

Investigational Site Number : 2002

Essen, , Germany

Site Status

Investigational Site Number 2001

Halle, , Germany

Site Status

Investigational Site Number : 2001

Halle, , Germany

Site Status

Investigational Site Number 2005

Würzburg, , Germany

Site Status

Investigational Site Number : 2005

Würzburg, , Germany

Site Status

Investigational Site Number 1601

Pécs, , Hungary

Site Status

Investigational Site Number : 1601

Pécs, , Hungary

Site Status

Investigational Site Number 1401

Mumbai, , India

Site Status

Investigational Site Number : 1401

Mumbai, , India

Site Status

Investigational Site Number 1402

Vellore, , India

Site Status

Investigational Site Number : 1402

Vellore, , India

Site Status

Investigational Site Number 2506

Catania, , Italy

Site Status

Investigational Site Number : 2506

Catania, , Italy

Site Status

Investigational Site Number 2502

Milan, , Italy

Site Status

Investigational Site Number : 2502

Milan, , Italy

Site Status

Investigational Site Number 2503

Napoli, , Italy

Site Status

Investigational Site Number : 2503

Napoli, , Italy

Site Status

Investigational Site Number 2501

Pisa, , Italy

Site Status

Investigational Site Number : 2501

Pisa, , Italy

Site Status

Investigational Site Number 2505

Roma, , Italy

Site Status

Investigational Site Number : 2505

Roma, , Italy

Site Status

Investigational Site Number 2504

Siena, , Italy

Site Status

Investigational Site Number : 2504

Siena, , Italy

Site Status

Investigational Site Number 2403

Ciudad Madero, , Mexico

Site Status

Investigational Site Number 2402

Mexico City, , Mexico

Site Status

Investigational Site Number 2404

México, , Mexico

Site Status

Investigational Site Number : 2404

México, , Mexico

Site Status

Investigational Site Number 2902

Groningen, , Netherlands

Site Status

Investigational Site Number : 2902

Groningen, , Netherlands

Site Status

Investigational Site Number 2901

Utrecht, , Netherlands

Site Status

Investigational Site Number : 2901

Utrecht, , Netherlands

Site Status

Investigational Site Number : 1702

Poznan, Greater Poland Voivodeship, Poland

Site Status

Investigational Site Number : 1703

Warsaw, Masovian Voivodeship, Poland

Site Status

Investigational Site Number 1701

Gliwice, , Poland

Site Status

Investigational Site Number : 1701

Gliwice, , Poland

Site Status

Investigational Site Number 1702

Poznan, , Poland

Site Status

Investigational Site Number 1703

Warsaw, , Poland

Site Status

Investigational Site Number 2602

Coimbra, , Portugal

Site Status

Investigational Site Number 2601

Lisbon, , Portugal

Site Status

Investigational Site Number : 2601

Lisbon, , Portugal

Site Status

Investigational Site Number 1801

Bucharest, , Romania

Site Status

Investigational Site Number 3301

Obninsk, , Russia

Site Status

Investigational Site Number : 3301

Obninsk, , Russia

Site Status

Investigational Site Number 3401

Belgrade, , Serbia

Site Status

Investigational Site Number : 3401

Belgrade, , Serbia

Site Status

Investigational Site Number 3402

Belgrade, , Serbia

Site Status

Investigational Site Number : 3402

Belgrade, , Serbia

Site Status

Investigational Site Number : 1501

Seoul, , South Korea

Site Status

Investigational Site Number 1501

Seoul, , South Korea

Site Status

Investigational Site Number : 3002

Pamplona, Navarre, Spain

Site Status

Investigational Site Number 3003

Madrid, , Spain

Site Status

Investigational Site Number : 3003

Madrid, , Spain

Site Status

Investigational Site Number 3001

Madrid, , Spain

Site Status

Investigational Site Number : 3001

Madrid, , Spain

Site Status

Investigational Site Number 3002

Pamplona, , Spain

Site Status

Investigational Site Number 3102

Stockholm, , Sweden

Site Status

Investigational Site Number : 3102

Stockholm, , Sweden

Site Status

Investigational Site Number 3101

Uppsala, , Sweden

Site Status

Investigational Site Number : 3101

Uppsala, , Sweden

Site Status

Investigational Site Number 2101

Basel, , Switzerland

Site Status

Investigational Site Number : 2101

Basel, , Switzerland

Site Status

Investigational Site Number 2102

Bern, , Switzerland

Site Status

Investigational Site Number : 2102

Bern, , Switzerland

Site Status

Countries

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United States Australia Austria Belgium Brazil Canada Czechia Denmark France Germany Hungary India Italy Mexico Netherlands Poland Portugal Romania Russia Serbia South Korea Spain Sweden Switzerland

References

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Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24.

Reference Type RESULT
PMID: 22025146 (View on PubMed)

Related Links

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Other Identifiers

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LPS14811

Identifier Type: OTHER

Identifier Source: secondary_id

2005-005077-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D4200C00058

Identifier Type: -

Identifier Source: org_study_id

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