An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
- Conditions
- Thyroid Cancer
- Interventions
- Drug: ZD6474 (Vandetanib)
- Registration Number
- NCT00410761
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 437
- Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.
- Presence of measurable tumor
- Able to swallow medication
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 ZD6474 (Vandetanib) Vandetanib
- Primary Outcome Measures
Name Time Method Progression-Free Survival(PFS) 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then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.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
Name Time Method Biochemical Response Calcitonin (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 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.
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. 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.Biochemical Response Carcinoembryonic Antigen (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 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.
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 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
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 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
Overall Survival (OS) Number of deaths since randomisation As data was immature at data cut off, number of death events is quoted
Time to Worsening of Pain (TWP) 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.
Trial Locations
- Locations (127)
University Arkansas Site Number : 3
🇺🇸Little Rock, Arkansas, United States
USCF / Mt Zion Medical Center Site Number : 8
🇺🇸San Francisco, California, United States
University Of Colorado Health Sciences Center Site Number : 9
🇺🇸Aurora, Colorado, United States
Yale University School Medicine Site Number : 11
🇺🇸New Haven, Connecticut, United States
Mayo Clinic- Site Number : 15
🇺🇸Jacksonville, Florida, United States
The University Of Chicago Site Number : 18
🇺🇸Chicago, Illinois, United States
The University Of Kentucky Site Number : 17
🇺🇸Lexington, Kentucky, United States
Dana Farber Cancer Institute Site Number : 2
🇺🇸Boston, Massachusetts, United States
Wayne State University / Harper Hospital Site Number : 7
🇺🇸Detroit, Michigan, United States
Mayo Clinic- Site Number : 14
🇺🇸Rochester, Minnesota, United States
Washington University School Of Med Site Number : 10
🇺🇸Saint Louis, Missouri, United States
University Of Cincinnati Site Number : 6
🇺🇸Cincinnati, Ohio, United States
Oregon Health & Science University- Site Number : 22
🇺🇸Portland, Oregon, United States
Medical University of South Carolina- Site Number : 19
🇺🇸Charleston, South Carolina, United States
Anderson Cancer Center Site Number : 13
🇺🇸Houston, Texas, United States
Fletcher Allen Health Care Site Number : 21
🇺🇸Burlington, Vermont, United States
Investigational Site Number : 1901
🇦🇹Wien, Austria
Investigational Site Number : 1101
🇧🇪Anderlecht, Belgium
Investigational Site Number : 1102
🇧🇪Leuven, Belgium
Hospital De Clinicas De Porto Alegre- Site Number : 2301
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Faculdade de Medicina de Ribeirao Preto - USP- Site Number : 2302
🇧🇷Ribeirao Preto, São Paulo, Brazil
Investigational Site Number : 1203
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1201
🇨🇦Moncton, New Brunswick, Canada
Investigational Site Number : 1202
🇨🇦London, Ontario, Canada
Investigational Site Number : 1205
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1204
🇨🇦Sherbrooke, Quebec, Canada
Investigational Site Number : 3601
🇨🇿Praha 5, Czechia
Investigational Site Number : 2701
🇩🇰Odense C, Denmark
Investigational Site Number : 2802
🇫🇷BORDEAUX Cedex, France
Investigational Site Number : 2803
🇫🇷LYON Cedex 8, France
Investigational Site Number : 2801
🇫🇷Villejuif, France
Investigational Site Number : 2002
🇩🇪Essen, Germany
Investigational Site Number : 2001
🇩🇪Halle, Germany
Investigational Site Number : 2005
🇩🇪Würzburg, Germany
Investigational Site Number : 1601
🇭🇺Pécs, Hungary
Investigational Site Number : 1401
🇮🇳Mumbai, India
Investigational Site Number : 1402
🇮🇳Vellore, India
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, Italy
Investigational Site Number : 1501
🇰🇷Seoul, Korea, Republic of
Investigational Site Number : 2404
🇲🇽México, Mexico
Investigational Site Number : 2902
🇳🇱Groningen, Netherlands
Investigational Site Number : 2901
🇳🇱Utrecht, Netherlands
Investigational Site Number : 1703
🇵🇱Warszawa, Mazowieckie, Poland
Investigational Site Number : 1702
🇵🇱Poznan, Wielkopolskie, Poland
Investigational Site Number : 1701
🇵🇱Gliwice, Poland
Investigational Site Number : 2601
🇵🇹Lisboa, Portugal
Investigational Site Number : 3301
🇷🇺Obninsk, Russian Federation
Investigational Site Number : 3402
🇷🇸Belgrade, Serbia
Investigational Site Number : 3401
🇷🇸Belgrad, Serbia
Investigational Site Number : 3002
🇪🇸Pamplona, Navarra, Spain
Investigational Site Number : 3003
🇪🇸Madrid, Spain
Investigational Site Number : 3001
🇪🇸Madrid, Spain
Investigational Site Number : 3102
🇸🇪Stockholm, Sweden
Investigational Site Number : 3101
🇸🇪Uppsala, Sweden
Investigational Site Number : 2101
🇨🇭Basel, Switzerland
Investigational Site Number : 2102
🇨🇭Bern, Switzerland
Investigational Site Number 3
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8
🇺🇸San Francisco, California, United States
Investigational Site Number 9
🇺🇸Aurora, Colorado, United States
Investigational Site Number 11
🇺🇸New Haven, Connecticut, United States
Investigational Site Number 15
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 18
🇺🇸Chicago, Illinois, United States
Investigational Site Number 17
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 2
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 7
🇺🇸Detroit, Michigan, United States
Investigational Site Number 14
🇺🇸Rochester, Minnesota, United States
Investigational Site Number 10
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 6
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 22
🇺🇸Portland, Oregon, United States
Investigational Site Number 19
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 13
🇺🇸Houston, Texas, United States
Investigational Site Number 21
🇺🇸Burlington, Vermont, United States
Investigational Site Number 1001
🇦🇺St Leonards, Australia
Investigational Site Number 1901
🇦🇹Wien, Austria
Investigational Site Number 1101
🇧🇪Bruxelles, Belgium
Investigational Site Number 1102
🇧🇪Leuven, Belgium
Investigational Site Number 2301
🇧🇷Porto Alegre, Brazil
Investigational Site Number 2302
🇧🇷Ribeirão Preto, Brazil
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, Canada
Investigational Site Number 3601
🇨🇿Praha 5, Czechia
Investigational Site Number 2701
🇩🇰Odense C, Denmark
Investigational Site Number 2802
🇫🇷BORDEAUX Cedex, France
Investigational Site Number 2803
🇫🇷LYON Cedex 8, France
Investigational Site Number 2801
🇫🇷Villejuif, France
Investigational Site Number 2002
🇩🇪Essen, Germany
Investigational Site Number 2001
🇩🇪Halle, Germany
Investigational Site Number 2005
🇩🇪Würzburg, Germany
Investigational Site Number 1601
🇭🇺Pécs, Hungary
Investigational Site Number 1401
🇮🇳Mumbai, India
Investigational Site Number 1402
🇮🇳Vellore, India
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, Italy
Investigational Site Number 1501
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 2403
🇲🇽Cd. Madero, Mexico
Investigational Site Number 2402
🇲🇽Mexico City, Mexico
Investigational Site Number 2404
🇲🇽México, Mexico
Investigational Site Number 2902
🇳🇱Groningen, Netherlands
Investigational Site Number 2901
🇳🇱Utrecht, Netherlands
Investigational Site Number 1701
🇵🇱Gliwice, Poland
Investigational Site Number 1702
🇵🇱Poznan, Poland
Investigational Site Number 1703
🇵🇱Warszawa, Poland
Investigational Site Number 2602
🇵🇹Coimbra, Portugal
Investigational Site Number 2601
🇵🇹Lisboa, Portugal
Investigational Site Number 1801
🇷🇴Bucarest, Romania
Investigational Site Number 3301
🇷🇺Obninsk, Russian Federation
Investigational Site Number 3402
🇷🇸Belgrade, Serbia
Investigational Site Number 3401
🇷🇸Belgrad, Serbia
Investigational Site Number 3003
🇪🇸Madrid, Spain
Investigational Site Number 3001
🇪🇸Madrid, Spain
Investigational Site Number 3002
🇪🇸Pamplona, Spain
Investigational Site Number 3102
🇸🇪Stockholm, Sweden
Investigational Site Number 3101
🇸🇪Uppsala, Sweden
Investigational Site Number 2101
🇨🇭Basel, Switzerland
Investigational Site Number 2102
🇨🇭Bern, Switzerland