TriangleNCT00410761 · CITED IN SOURCE DOCUMENTS
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-09-24
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-Free Survival(PFS)
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DoR)
Overall Survival (OS)
Biochemical Response Calcitonin (CTN)
Biochemical Response Carcinoembryonic Antigen (CEA)
Time to Worsening of Pain (TWP)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Placebo vandetanib
- label
- 1
- type
- NO_INTERVENTION
- description
- Vandetanib
- intervention Names
- Drug: ZD6474 (Vandetanib)
- label
- 2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 2
- description
- once daily oral tablet
- name
- ZD6474 (Vandetanib)
- other Names
- ZACTIMA™
- SAR390530
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 331
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- 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.
- secondary Outcomes
- description
- 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.
- measure
- 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.
- description
- 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
- measure
- 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
- description
- 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
- measure
- 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
- description
- OS is defined as the time from the date of randomization until death.
- measure
- Overall Survival (OS)
- time Frame
- From date of randomization until death, up to approximately 105 months
- description
- 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.
- measure
- Biochemical Response Calcitonin (CTN)
- time Frame
- 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
- description
- 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.
- measure
- 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
- description
- 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.
- measure
- 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.
Full study description
- 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.
Source references
- references
- citation
- 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
- type
- RESULT
- see Also Links
Source notices and limitations
Discovery and provenance
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- 14 CLINICAL STUDIES 14.1 Clinical Trial in Patients with Medullary Thyroid Cancer A double-blind, placebo-controlled study (Study D4200C00058, NCT00410761) randomized patients with unresectable locally advanced or metastatic medullary thyroid cancer to CAPRELSA 300 mg (n=231) versus placebo (n=100). The major eff
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- oskeletal Disorders Muscle Spasms 6 0 1 0 Other Clinically Relevant Adverse Effects In patients with medullary thyroid cancer treated with CAPRELSA or placebo (NCT00410761), clinically important uncommon adverse drug reactions included pancreatitis (0.4% vs 0%), intestinal perforation (0.4% vs 0%), and heart failure (0.9% vs 0%).
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Preserved source evidence · Not medical advice