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An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00410761
Recruitment Status : Active, not recruiting
First Posted : December 13, 2006
Results First Posted : March 26, 2012
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: ZD6474 (Vandetanib) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 30, 2006
Actual Primary Completion Date : July 2009
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
No Intervention: 1
Placebo vandetanib
Experimental: 2
Vandetanib
Drug: ZD6474 (Vandetanib)
once daily oral tablet
Other Names:
  • ZACTIMA™
  • SAR390530




Primary Outcome Measures :
  1. 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then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent. ]
    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.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 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. ]

    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.


  2. Disease Control Rate (DCR) [ 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 ]
    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

  3. Duration of Response (DoR) [ 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 ]
    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

  4. Overall Survival (OS) [ Time Frame: Number of deaths since randomisation ]
    As data was immature at data cut off, number of death events is quoted

  5. Biochemical Response Calcitonin (CTN) [ Time Frame: Blood samples 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 ]
    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.

  6. Biochemical Response Carcinoembryonic Antigen (CEA) [ Time Frame: 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 ]
    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.

  7. Time to Worsening of Pain (TWP) [ Time Frame: 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. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410761


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Locations
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United States, Arkansas
Investigational Site Number 3
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 8
San Francisco, California, United States, 94115
United States, Colorado
Investigational Site Number 9
Aurora, Colorado, United States, 80010
United States, Connecticut
Investigational Site Number 11
New Haven, Connecticut, United States, 06510
United States, Florida
Investigational Site Number 15
Jacksonville, Florida, United States, 32224
United States, Illinois
Investigational Site Number 18
Chicago, Illinois, United States, 60637
United States, Kentucky
Investigational Site Number 17
Lexington, Kentucky, United States, 40536-0298
United States, Massachusetts
Investigational Site Number 2
Boston, Massachusetts, United States, 02115
United States, Michigan
Investigational Site Number 7
Detroit, Michigan, United States, 48201
United States, Minnesota
Investigational Site Number 14
Rochester, Minnesota, United States, 55905
United States, Missouri
Investigational Site Number 10
Saint Louis, Missouri, United States, 63110
United States, Ohio
Investigational Site Number 6
Cincinnati, Ohio, United States, 45267-0589
United States, Oregon
Investigational Site Number 22
Portland, Oregon, United States, 97239
United States, South Carolina
Investigational Site Number 19
Charleston, South Carolina, United States, 29425
United States, Texas
Investigational Site Number 13
Houston, Texas, United States, 77030
United States, Vermont
Investigational Site Number 21
Burlington, Vermont, United States, 05401
Australia
Investigational Site Number 1001
St Leonards, Australia, 2065
Austria
Investigational Site Number 1901
Wien, Austria, 1901
Belgium
Investigational Site Number 1101
Bruxelles, Belgium, 1000
Investigational Site Number 1102
Leuven, Belgium, 3000
Brazil
Investigational Site Number 2301
Porto Alegre, Brazil, 90035-003
Investigational Site Number 2302
Ribeirão Preto, Brazil, 14048-900
Canada
Investigational Site Number 1203
Calgary, Canada, T2E7C5
Investigational Site Number 1202
London, Canada, N6A 4L6
Investigational Site Number 1201
Moncton, Canada, E1C6Z8
Investigational Site Number 1204
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 1205
Toronto, Canada, M5G2M9
Czechia
Investigational Site Number 3601
Praha 5, Czechia, 15006
Denmark
Investigational Site Number 2701
Odense C, Denmark, 5000
France
Investigational Site Number 2802
BORDEAUX Cedex, France, 33076
Investigational Site Number 2803
LYON Cedex 8, France, 69373
Investigational Site Number 2801
Villejuif, France, 94800
Germany
Investigational Site Number 2002
Essen, Germany, 45122
Investigational Site Number 2001
Halle, Germany, 06120
Investigational Site Number 2005
Würzburg, Germany, 97080
Hungary
Investigational Site Number 1601
Pécs, Hungary, 7624
India
Investigational Site Number 1401
Mumbai, India, 400012
Investigational Site Number 1402
Vellore, India, 632004
Italy
Investigational Site Number 2506
Catania, Italy
Investigational Site Number 2502
Milano, Italy
Investigational Site Number 2503
Napoli, Italy, 80131
Investigational Site Number 2501
Pisa, Italy, 56124
Investigational Site Number 2505
Roma, Italy, 00161
Investigational Site Number 2504
Siena, Italy, 53100
Korea, Republic of
Investigational Site Number 1501
Seoul, Korea, Republic of
Mexico
Investigational Site Number 2403
Cd. Madero, Mexico
Investigational Site Number 2402
Mexico City, Mexico, 14000
Investigational Site Number 2404
México, Mexico, 06726
Netherlands
Investigational Site Number 2902
Groningen, Netherlands
Investigational Site Number 2901
Utrecht, Netherlands
Poland
Investigational Site Number 1701
Gliwice, Poland, 44-101
Investigational Site Number 1702
Poznan, Poland, 60-355
Investigational Site Number 1703
Warszawa, Poland, 02-781
Portugal
Investigational Site Number 2602
Coimbra, Portugal, 3000-75
Investigational Site Number 2601
Lisboa, Portugal, 1099-023
Romania
Investigational Site Number 1801
Bucarest, Romania
Russian Federation
Investigational Site Number 3301
Obninsk, Russian Federation, 249036
Serbia
Investigational Site Number 3402
Belgrade, Serbia
Investigational Site Number 3401
Belgrad, Serbia, 11000
Spain
Investigational Site Number 3003
Madrid, Spain, 28040
Investigational Site Number 3001
Madrid, Spain, 28041
Investigational Site Number 3002
Pamplona, Spain, 31008
Sweden
Investigational Site Number 3102
Stockholm, Sweden, 17176
Investigational Site Number 3101
Uppsala, Sweden, 75185
Switzerland
Investigational Site Number 2101
Basel, Switzerland, 4031
Investigational Site Number 2102
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00410761     History of Changes
Other Study ID Numbers: D4200C00058
2005-005077-29 ( EudraCT Number )
LPS14811 ( Other Identifier: Sanofi )
First Posted: December 13, 2006    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
ZD6474
MTC
Hereditary Medullary Thyroid Cancer
Sporadic Medullary Thyroid Cancer
Medullary Thyroid Cancer

Additional relevant MeSH terms:
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Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Thyroid Diseases
Carcinoma, Neuroendocrine
Endocrine System Diseases
Adenocarcinoma
Carcinoma