An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

NCT00410761 | Completed Phase 3 Results

• 3 other identifiers: D4200C00058LPS148112005-005077-29
• Study Type: interventional
• Target: 331
• Locations: 22 countries
• Sites: 121

Brief Summary

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.

Conditions

Thyroid Cancer

Keywords

ZD6474; MTC; Hereditary Medullary Thyroid Cancer; Sporadic Medullary Thyroid Cancer; Medullary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival(PFS)

  Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.

  RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.

• Disease Control Rate (DCR)

  RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent

• Duration of Response (DoR)

  RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent

• Overall Survival (OS)

  From date of randomization until death, up to approximately 105 months

• Biochemical Response Calcitonin (CTN)

  Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up

Study Arms (2)

1

NO INTERVENTION

Placebo vandetanib

2

EXPERIMENTAL

Vandetanib

Drug: ZD6474 (Vandetanib)

Interventions

ZD6474 (Vandetanib) DRUG

once daily oral tablet

Also known as: ZACTIMA™, SAR390530

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (127)

Investigational Site Number 3

Little Rock, Arkansas, 72205, United States

Location

University Arkansas Site Number : 3

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 8

San Francisco, California, 94115, United States

Location

USCF / Mt Zion Medical Center Site Number : 8

San Francisco, California, 94115, United States

Location

Investigational Site Number 9

Aurora, Colorado, 80010, United States

Location

University Of Colorado Health Sciences Center Site Number : 9

Aurora, Colorado, 80010, United States

Location

Investigational Site Number 11

New Haven, Connecticut, 06510, United States

Location

Yale University School Medicine Site Number : 11

New Haven, Connecticut, 06510, United States

Location

Investigational Site Number 15

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic- Site Number : 15

Jacksonville, Florida, 32224, United States

Location

Investigational Site Number 18

Chicago, Illinois, 60637, United States

Location

The University Of Chicago Site Number : 18

Chicago, Illinois, 60637, United States

Location

Investigational Site Number 17

Lexington, Kentucky, 40536-0298, United States

Location

The University Of Kentucky Site Number : 17

Lexington, Kentucky, 40536-0298, United States

Location

Dana Farber Cancer Institute Site Number : 2

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 2

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 7

Detroit, Michigan, 48201, United States

Location

Wayne State University / Harper Hospital Site Number : 7

Detroit, Michigan, 48201, United States

Location

Investigational Site Number 14

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic- Site Number : 14

Rochester, Minnesota, 55905, United States

Location

Investigational Site Number 10

St Louis, Missouri, 63110, United States

Location

Washington University School Of Med Site Number : 10

St Louis, Missouri, 63110, United States

Location

Investigational Site Number 6

Cincinnati, Ohio, 45267-0589, United States

Location

University Of Cincinnati Site Number : 6

Cincinnati, Ohio, 45267-0589, United States

Location

Investigational Site Number 22

Portland, Oregon, 97239, United States

Location

Oregon Health & Science University- Site Number : 22

Portland, Oregon, 97239, United States

Location

Investigational Site Number 19

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina- Site Number : 19

Charleston, South Carolina, 29425, United States

Location

Anderson Cancer Center Site Number : 13

Houston, Texas, 77030, United States

Location

Investigational Site Number 13

Houston, Texas, 77030, United States

Location

Fletcher Allen Health Care Site Number : 21

Burlington, Vermont, 05401, United States

Location

Investigational Site Number 21

Burlington, Vermont, 05401, United States

Location

Investigational Site Number 1001

St Leonards, 2065, Australia

Location

Investigational Site Number 1901

Vienna, 1901, Austria

Location

Investigational Site Number : 1901

Vienna, 1901, Austria

Location

Investigational Site Number : 1101

Anderlecht, 1070, Belgium

Location

Investigational Site Number 1101

Brussels, 1000, Belgium

Location

Investigational Site Number 1102

Leuven, 3000, Belgium

Location

Investigational Site Number : 1102

Leuven, 3000, Belgium

Location

Hospital De Clinicas De Porto Alegre- Site Number : 2301

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Investigational Site Number 2301

Porto Alegre, 90035-003, Brazil

Location

Investigational Site Number 2302

Ribeirão Preto, 14048-900, Brazil

Location

Investigational Site Number : 1203

Calgary, Alberta, T2E7C5, Canada

Location

Investigational Site Number : 1201

Moncton, New Brunswick, E1C6Z8, Canada

Location

Investigational Site Number : 1202

London, Ontario, N6A 4L6, Canada

Location

Investigational Site Number : 1205

Toronto, Ontario, M5G2M9, Canada

Location

Investigational Site Number : 1204

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Investigational Site Number 1203

Calgary, T2E7C5, Canada

Location

Investigational Site Number 1202

London, N6A 4L6, Canada

Location

Investigational Site Number 1201

Moncton, E1C6Z8, Canada

Location

Investigational Site Number 1204

Sherbrooke, J1H 5N4, Canada

Location

Investigational Site Number 1205

Toronto, M5G2M9, Canada

Location

Investigational Site Number 3601

Prague, 15006, Czechia

Location

Investigational Site Number : 3601

Prague, 15006, Czechia

Location

Investigational Site Number 2701

Odense C, 5000, Denmark

Location

Investigational Site Number : 2701

Odense C, 5000, Denmark

Location

Investigational Site Number 2802

Bordeaux, 33076, France

Location

Investigational Site Number : 2802

Bordeaux, 33076, France

Location

Investigational Site Number 2803

Lyon, 69373, France

Location

Investigational Site Number : 2803

Lyon, 69373, France

Location

Investigational Site Number 2801

Villejuif, 94800, France

Location

Investigational Site Number : 2801

Villejuif, 94800, France

Location

Investigational Site Number 2002

Essen, 45122, Germany

Location

Investigational Site Number : 2002

Essen, 45122, Germany

Location

Investigational Site Number 2001

Halle, 06120, Germany

Location

Investigational Site Number : 2001

Halle, 06120, Germany

Location

Investigational Site Number 2005

Würzburg, 97080, Germany

Location

Investigational Site Number : 2005

Würzburg, 97080, Germany

Location

Investigational Site Number 1601

Pécs, 7624, Hungary

Location

Investigational Site Number : 1601

Pécs, 7624, Hungary

Location

Investigational Site Number 1401

Mumbai, 400012, India

Location

Investigational Site Number : 1401

Mumbai, 400012, India

Location

Investigational Site Number 1402

Vellore, 632004, India

Location

Investigational Site Number : 1402

Vellore, 632004, India

Location

Investigational Site Number 2506

Catania, Italy

Location

Investigational Site Number : 2506

Catania, Italy

Location

Investigational Site Number 2502

Milan, Italy

Location

Investigational Site Number : 2502

Milan, Italy

Location

Investigational Site Number 2503

Napoli, 80131, Italy

Location

Investigational Site Number : 2503

Napoli, 80131, Italy

Location

Investigational Site Number 2501

Pisa, 56124, Italy

Location

Investigational Site Number : 2501

Pisa, 56124, Italy

Location

Investigational Site Number 2505

Roma, 00161, Italy

Location

Investigational Site Number : 2505

Roma, 00161, Italy

Location

Investigational Site Number 2504

Siena, 53100, Italy

Location

Investigational Site Number : 2504

Siena, 53100, Italy

Location

Investigational Site Number 2403

Ciudad Madero, Mexico

Location

Investigational Site Number 2402

Mexico City, 14000, Mexico

Location

Investigational Site Number 2404

México, 06726, Mexico

Location

Investigational Site Number : 2404

México, 06726, Mexico

Location

Investigational Site Number 2902

Groningen, Netherlands

Location

Investigational Site Number : 2902

Groningen, Netherlands

Location

Investigational Site Number 2901

Utrecht, Netherlands

Location

Investigational Site Number : 2901

Utrecht, Netherlands

Location

Investigational Site Number : 1702

Poznan, Greater Poland Voivodeship, 60-355, Poland

Location

Investigational Site Number : 1703

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Investigational Site Number 1701

Gliwice, 44-101, Poland

Location

Investigational Site Number : 1701

Gliwice, 44-101, Poland

Location

Investigational Site Number 1702

Poznan, 60-355, Poland

Location

Investigational Site Number 1703

Warsaw, 02-781, Poland

Location

Investigational Site Number 2602

Coimbra, 3000-75, Portugal

Location

Investigational Site Number 2601

Lisbon, 1099-023, Portugal

Location

Investigational Site Number : 2601

Lisbon, 1099-023, Portugal

Location

Investigational Site Number 1801

Bucharest, Romania

Location

Investigational Site Number 3301

Obninsk, 249036, Russia

Location

Investigational Site Number : 3301

Obninsk, 249036, Russia

Location

Investigational Site Number 3401

Belgrade, 11000, Serbia

Location

Investigational Site Number : 3401

Belgrade, 11000, Serbia

Location

Investigational Site Number 3402

Belgrade, Serbia

Location

Investigational Site Number : 3402

Belgrade, Serbia

Location

Investigational Site Number : 1501

Seoul, 03080, South Korea

Location

Investigational Site Number 1501

Seoul, South Korea

Location

Investigational Site Number : 3002

Pamplona, Navarre, 31008, Spain

Location

Investigational Site Number 3003

Madrid, 28040, Spain

Location

Investigational Site Number : 3003

Madrid, 28040, Spain

Location

Investigational Site Number 3001

Madrid, 28041, Spain

Location

Investigational Site Number : 3001

Madrid, 28041, Spain

Location

Investigational Site Number 3002

Pamplona, 31008, Spain

Location

Investigational Site Number 3102

Stockholm, 17176, Sweden

Location

Investigational Site Number : 3102

Stockholm, 17176, Sweden

Location

Investigational Site Number 3101

Uppsala, 75185, Sweden

Location

Investigational Site Number : 3101

Uppsala, 75185, Sweden

Location

Investigational Site Number 2101

Basel, 4031, Switzerland

Location

Investigational Site Number : 2101

Basel, 4031, Switzerland

Location

Investigational Site Number 2102

Bern, CH-3010, Switzerland

Location

Investigational Site Number : 2102

Bern, CH-3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22025146 RESULT

Related Links

• CSR-D4200C00058.pdf

MeSH Terms

Conditions

Thyroid Neoplasms; Familial medullary thyroid carcinoma; Carcinoma, Medullary

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 13, 2006
• Study Start: November 23, 2006
• Primary Completion: July 31, 2009
• Study Completion: July 26, 2024
• Last Updated: September 24, 2025
• Results First Posted: March 26, 2012

Record last verified: 2025-09

Locations

RO (1); IN (4); PT (3); HU (2); NL (4); PL (6); ES (6); SE (4); CH (4); CZ (2); DK (2); RU (2); BR (4); KR (2); AU (1); US (32); BE (4); CA (10); FR (6); IT (12); ME (4); DE (6)