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Thyroid CancerPhase 3NCT00410761

An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

A Phase 3 study testing ZD6474 (Vandetanib) in people with Thyroid Cancer, run by Genzyme, a Sanofi Company at 127 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
ZD6474 (Vandetanib)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
331 participants
Where
127 sitesin 24 countries
Study dates
23 Nov 2006to 26 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

127 sites in 24 countries.

127 sites in 24 countries

United States32 sites

  • Investigational Site Number 9

    Aurora, Colorado, 80010

  • University Of Colorado Health Sciences Center Site Number : 9

    Aurora, Colorado, 80010

  • Dana Farber Cancer Institute Site Number : 2

    Boston, Massachusetts, 02115

  • Investigational Site Number 2

    Boston, Massachusetts, 02115

  • Fletcher Allen Health Care Site Number : 21

    Burlington, Vermont, 05401

  • Investigational Site Number 21

    Burlington, Vermont, 05401

  • Investigational Site Number 19

    Charleston, South Carolina, 29425

  • Medical University of South Carolina- Site Number : 19

    Charleston, South Carolina, 29425

  • Investigational Site Number 18

    Chicago, Illinois, 60637

  • The University Of Chicago Site Number : 18

    Chicago, Illinois, 60637

  • Investigational Site Number 6

    Cincinnati, Ohio, 45267-0589

  • University Of Cincinnati Site Number : 6

    Cincinnati, Ohio, 45267-0589

  • Investigational Site Number 7

    Detroit, Michigan, 48201

  • Wayne State University / Harper Hospital Site Number : 7

    Detroit, Michigan, 48201

  • Anderson Cancer Center Site Number : 13

    Houston, Texas, 77030

  • Investigational Site Number 13

    Houston, Texas, 77030

  • Investigational Site Number 15

    Jacksonville, Florida, 32224

  • Mayo Clinic- Site Number : 15

    Jacksonville, Florida, 32224

  • Investigational Site Number 17

    Lexington, Kentucky, 40536-0298

  • The University Of Kentucky Site Number : 17

    Lexington, Kentucky, 40536-0298

  • Investigational Site Number 3

    Little Rock, Arkansas, 72205

  • University Arkansas Site Number : 3

    Little Rock, Arkansas, 72205

  • Investigational Site Number 11

    New Haven, Connecticut, 06510

  • Yale University School Medicine Site Number : 11

    New Haven, Connecticut, 06510

  • Investigational Site Number 22

    Portland, Oregon, 97239

  • Oregon Health & Science University- Site Number : 22

    Portland, Oregon, 97239

  • Investigational Site Number 14

    Rochester, Minnesota, 55905

  • Mayo Clinic- Site Number : 14

    Rochester, Minnesota, 55905

  • Investigational Site Number 8

    San Francisco, California, 94115

  • USCF / Mt Zion Medical Center Site Number : 8

    San Francisco, California, 94115

  • Investigational Site Number 10

    St Louis, Missouri, 63110

  • Washington University School Of Med Site Number : 10

    St Louis, Missouri, 63110

Other trials in United States

Italy12 sites

  • Investigational Site Number 2506

    Catania

  • Investigational Site Number : 2506

    Catania

  • Investigational Site Number 2502

    Milan

  • Investigational Site Number : 2502

    Milan

  • Investigational Site Number 2503

    Naples, 80131

  • Investigational Site Number : 2503

    Naples, 80131

  • Investigational Site Number 2501

    Pisa, 56124

  • Investigational Site Number : 2501

    Pisa, 56124

  • Investigational Site Number 2505

    Roma, 00161

  • Investigational Site Number : 2505

    Roma, 00161

  • Investigational Site Number 2504

    Siena, 53100

  • Investigational Site Number : 2504

    Siena, 53100

Other trials in Italy

Canada10 sites

  • Investigational Site Number : 1203

    Calgary, Alberta, T2E7C5

  • Investigational Site Number 1203

    Calgary, T2E7C5

  • Investigational Site Number : 1202

    London, Ontario, N6A 4L6

  • Investigational Site Number 1202

    London, N6A 4L6

  • Investigational Site Number : 1201

    Moncton, New Brunswick, E1C6Z8

  • Investigational Site Number 1201

    Moncton, E1C6Z8

  • Investigational Site Number : 1204

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number 1204

    Sherbrooke, J1H 5N4

  • Investigational Site Number : 1205

    Toronto, Ontario, M5G2M9

  • Investigational Site Number 1205

    Toronto, M5G2M9

Other trials in Canada

France6 sites

  • Investigational Site Number 2802

    Bordeaux, 33076

  • Investigational Site Number : 2802

    Bordeaux, 33076

  • Investigational Site Number 2803

    Lyon, 69373

  • Investigational Site Number : 2803

    Lyon, 69373

  • Investigational Site Number 2801

    Villejuif, 94800

  • Investigational Site Number : 2801

    Villejuif, 94800

Other trials in France

Germany6 sites

  • Investigational Site Number 2002

    Essen, 45122

  • Investigational Site Number : 2002

    Essen, 45122

  • Investigational Site Number 2001

    Halle, 06120

  • Investigational Site Number : 2001

    Halle, 06120

  • Investigational Site Number 2005

    Würzburg, 97080

  • Investigational Site Number : 2005

    Würzburg, 97080

Other trials in Germany

Poland6 sites

  • Investigational Site Number 1701

    Gliwice, 44-101

  • Investigational Site Number : 1701

    Gliwice, 44-101

  • Investigational Site Number : 1702

    Poznan, Greater Poland Voivodeship, 60-355

  • Investigational Site Number 1702

    Poznan, 60-355

  • Investigational Site Number : 1703

    Warsaw, Masovian Voivodeship, 02-781

  • Investigational Site Number 1703

    Warsaw, 02-781

Other trials in Poland

Spain6 sites

  • Investigational Site Number 3003

    Madrid, 28040

  • Investigational Site Number : 3003

    Madrid, 28040

  • Investigational Site Number 3001

    Madrid, 28041

  • Investigational Site Number : 3001

    Madrid, 28041

  • Investigational Site Number : 3002

    Pamplona, Navarre, 31008

  • Investigational Site Number 3002

    Pamplona, 31008

Other trials in Spain

Belgium4 sites

  • Investigational Site Number : 1101

    Anderlecht, 1070

  • Investigational Site Number 1101

    Brussels, 1000

  • Investigational Site Number 1102

    Leuven, 3000

  • Investigational Site Number : 1102

    Leuven, 3000

Other trials in Belgium

Brazil4 sites

  • Hospital De Clinicas De Porto Alegre- Site Number : 2301

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Investigational Site Number 2301

    Porto Alegre, 90035-003

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

    Ribeirão Preto, São Paulo, 14048-900

  • Investigational Site Number 2302

    Ribeirão Preto, 14048-900

Other trials in Brazil

India4 sites

  • Investigational Site Number 1401

    Mumbai, 400012

  • Investigational Site Number : 1401

    Mumbai, 400012

  • Investigational Site Number 1402

    Vellore, 632004

  • Investigational Site Number : 1402

    Vellore, 632004

Other trials in India

Mexico4 sites

  • Investigational Site Number 2403

    Ciudad Madero

  • Investigational Site Number 2404

    México, 06726

  • Investigational Site Number : 2404

    México, 06726

  • Investigational Site Number 2402

    Mexico City, 14000

Other trials in Mexico

Netherlands4 sites

  • Investigational Site Number 2902

    Groningen

  • Investigational Site Number : 2902

    Groningen

  • Investigational Site Number 2901

    Utrecht

  • Investigational Site Number : 2901

    Utrecht

Other trials in Netherlands

Serbia4 sites

  • Investigational Site Number 3401

    Belgrade, 11000

  • Investigational Site Number : 3401

    Belgrade, 11000

  • Investigational Site Number 3402

    Belgrade

  • Investigational Site Number : 3402

    Belgrade

Other trials in Serbia

Sweden4 sites

  • Investigational Site Number 3102

    Stockholm, 17176

  • Investigational Site Number : 3102

    Stockholm, 17176

  • Investigational Site Number 3101

    Uppsala, 75185

  • Investigational Site Number : 3101

    Uppsala, 75185

Other trials in Sweden

Switzerland4 sites

  • Investigational Site Number 2101

    Basel, 4031

  • Investigational Site Number : 2101

    Basel, 4031

  • Investigational Site Number 2102

    Bern, CH-3010

  • Investigational Site Number : 2102

    Bern, CH-3010

Other trials in Switzerland

Portugal3 sites

  • Investigational Site Number 2602

    Coimbra, 3000-75

  • Investigational Site Number 2601

    Lisbon, 1099-023

  • Investigational Site Number : 2601

    Lisbon, 1099-023

Other trials in Portugal

Austria2 sites

  • Investigational Site Number 1901

    Vienna, 1901

  • Investigational Site Number : 1901

    Vienna, 1901

Other trials in Austria

Czechia2 sites

  • Investigational Site Number 3601

    Prague, 15006

  • Investigational Site Number : 3601

    Prague, 15006

Other trials in Czechia

Denmark2 sites

  • Investigational Site Number 2701

    Odense C, 5000

  • Investigational Site Number : 2701

    Odense C, 5000

Other trials in Denmark

Hungary2 sites

  • Investigational Site Number 1601

    Pécs, 7624

  • Investigational Site Number : 1601

    Pécs, 7624

Other trials in Hungary

Russia2 sites

  • Investigational Site Number 3301

    Obninsk, 249036

  • Investigational Site Number : 3301

    Obninsk, 249036

Other trials in Russia

South Korea2 sites

  • Investigational Site Number : 1501

    Seoul, 03080

  • Investigational Site Number 1501

    Seoul

Other trials in South Korea

Australia1 site

  • Investigational Site Number 1001

    St Leonards, 2065

Other trials in Australia

Romania1 site

  • Investigational Site Number 1801

    Bucharest

Other trials in Romania

About this study

Official title: An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer

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
Being tested
ZD6474 (Vandetanib)
Keywords
ZD6474, MTC, Hereditary Medullary Thyroid Cancer, Sporadic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Medical subject headings
Thyroid Neoplasms, Familial medullary thyroid carcinoma, Carcinoma, Medullary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZD6474 (Vandetanib)Drug

    Also called ZACTIMA™, SAR390530

    once daily oral tablet

Study groups in NCT00410761
Study groupRoleWhat they receive
1No interventionPlacebo vandetanib
2ExperimentalVandetanib
Receives: Drug: ZD6474 (Vandetanib)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Objective Response Rate (ORR)

    The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.

    The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE.

    Measured: 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.

  2. Disease Control Rate (DCR)

    Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks

    Measured: 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

  3. Duration of Response (DoR)

    Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met

    Measured: 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

  4. Overall Survival (OS)

    OS is defined as the time from the date of randomization until death.

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

  5. Biochemical Response Calcitonin (CTN)

    Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.

    Measured: 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

  6. Biochemical Response Carcinoembryonic Antigen (CEA)

    Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.

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

  7. Time to Worsening of Pain (TWP)

    TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain. TWP results are presented.

    Measured: During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2006 (estimated)
  2. Study start23 Nov 2006
  3. Primary completion31 Jul 2009
  4. Study completion26 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410761
Sponsor's protocol ID
D4200C00058
Other IDs
LPS14811, 2005-005077-29, 2005
Status last verified
Sep 2025
First submitted
6 Dec 2006
Last updated
24 Sep 2025

Publications

  • 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.

    PubMed 22025146

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZD6474 (Vandetanib) in people with Thyroid Cancer, run by Genzyme, a Sanofi Company at 127 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Italy, Canada, France, Germany and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival(PFS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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