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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00410761
Other study ID # D4200C00058
Secondary ID 2005-005077-29LP
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 30, 2006
Est. completion date June 28, 2024

Study information

Verified date September 2023
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 437
Est. completion date June 28, 2024
Est. primary completion date July 31, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
ZD6474 (Vandetanib)
once daily oral tablet

Locations

Country Name City State
Australia Investigational Site Number 1001 St Leonards
Austria Investigational Site Number 1901 Wien
Belgium Investigational Site Number 1101 Bruxelles
Belgium Investigational Site Number 1102 Leuven
Brazil Investigational Site Number 2301 Porto Alegre
Brazil Investigational Site Number 2302 Ribeirão Preto
Canada Investigational Site Number 1203 Calgary
Canada Investigational Site Number 1202 London
Canada Investigational Site Number 1201 Moncton
Canada Investigational Site Number 1204 Sherbrooke
Canada Investigational Site Number 1205 Toronto
Czechia Investigational Site Number 3601 Praha 5
Denmark Investigational Site Number 2701 Odense C
France Investigational Site Number 2802 BORDEAUX Cedex
France Investigational Site Number 2803 LYON Cedex 8
France Investigational Site Number 2801 Villejuif
Germany Investigational Site Number 2002 Essen
Germany Investigational Site Number 2001 Halle
Germany Investigational Site Number 2005 Würzburg
Hungary Investigational Site Number 1601 Pécs
India Investigational Site Number 1401 Mumbai
India Investigational Site Number 1402 Vellore
Italy Investigational Site Number 2506 Catania
Italy Investigational Site Number 2502 Milano
Italy Investigational Site Number 2503 Napoli
Italy Investigational Site Number 2501 Pisa
Italy Investigational Site Number 2505 Roma
Italy Investigational Site Number 2504 Siena
Korea, Republic of Investigational Site Number 1501 Seoul
Mexico Investigational Site Number 2403 Cd. Madero
Mexico Investigational Site Number 2404 México
Mexico Investigational Site Number 2402 Mexico City
Netherlands Investigational Site Number 2902 Groningen
Netherlands Investigational Site Number 2901 Utrecht
Poland Investigational Site Number 1701 Gliwice
Poland Investigational Site Number 1702 Poznan
Poland Investigational Site Number 1703 Warszawa
Portugal Investigational Site Number 2602 Coimbra
Portugal Investigational Site Number 2601 Lisboa
Romania Investigational Site Number 1801 Bucarest
Russian Federation Investigational Site Number 3301 Obninsk
Serbia Investigational Site Number 3401 Belgrad
Serbia Investigational Site Number 3402 Belgrade
Spain Investigational Site Number 3001 Madrid
Spain Investigational Site Number 3003 Madrid
Spain Investigational Site Number 3002 Pamplona
Sweden Investigational Site Number 3102 Stockholm
Sweden Investigational Site Number 3101 Uppsala
Switzerland Investigational Site Number 2101 Basel
Switzerland Investigational Site Number 2102 Bern
United States Investigational Site Number 9 Aurora Colorado
United States Investigational Site Number 2 Boston Massachusetts
United States Investigational Site Number 21 Burlington Vermont
United States Investigational Site Number 19 Charleston South Carolina
United States Investigational Site Number 18 Chicago Illinois
United States Investigational Site Number 6 Cincinnati Ohio
United States Investigational Site Number 7 Detroit Michigan
United States Investigational Site Number 13 Houston Texas
United States Investigational Site Number 15 Jacksonville Florida
United States Investigational Site Number 17 Lexington Kentucky
United States Investigational Site Number 3 Little Rock Arkansas
United States Investigational Site Number 11 New Haven Connecticut
United States Investigational Site Number 22 Portland Oregon
United States Investigational Site Number 14 Rochester Minnesota
United States Investigational Site Number 10 Saint Louis Missouri
United States Investigational Site Number 8 San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  India,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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.
Secondary 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 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 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 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 Overall Survival (OS) As data was immature at data cut off, number of death events is quoted Number of deaths since randomisation
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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.
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