NCT00410761 · STUDY IN CONTEXT

An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

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secondary · POSTED

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.

Source null

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secondary · POSTED

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

Source null

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secondary · POSTED

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

DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median

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secondary · POSTED

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

Source null

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secondary · POSTED

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.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Brief Pain Inventory · Time to Worsening of Pain (TWP)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-thyroid-cancer-lenvima-a86d5f90
nct id: NCT00410761
qol key: qol-0007
source section id: NCT00410761-om-0007
source outcome index: 7
instrument: Brief Pain Inventory
instrument basis: matched 'brief pain inventory' in the study's own wording
scale title: Time to Worsening of Pain (TWP)
measure definition: 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.
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.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-thyroid-cancer-lenvima-a86d5f90
nct id: NCT00410761
trial label: An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 4
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0000
source section id
NCT00410761-om-0000
source outcome index
0
endpoint
Progression-Free Survival(PFS)
endpoint definition
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.
time origin
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.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0001
source section id
NCT00410761-om-0001
source outcome index
1
endpoint
Objective Response Rate (ORR)
endpoint definition
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.
time origin
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.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0002
source section id
NCT00410761-om-0002
source outcome index
2
endpoint
Disease Control Rate (DCR)
endpoint definition
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
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0003
source section id
NCT00410761-om-0003
source outcome index
3
endpoint
Duration of Response (DoR)
endpoint definition
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
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0004
source section id
NCT00410761-om-0004
source outcome index
4
endpoint
Overall Survival (OS)
endpoint definition
OS is defined as the time from the date of randomization until death.
time origin
From date of randomization until death, up to approximately 105 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0005
source section id
NCT00410761-om-0005
source outcome index
5
endpoint
Biochemical Response Calcitonin (CTN)
endpoint definition
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.
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0000
arm key
OG000
arm label
Vandetanib 300 mg
regimen
Vandetanib (300 mg daily)
analyzed count
231
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
Placebo daily
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0001
arm key
OG000
arm label
Vandetanib 300 mg
regimen
Vandetanib (300 mg daily)
analyzed count
231
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0001
arm key
OG001
arm label
Placebo
regimen
Placebo daily
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0002
arm key
OG000
arm label
Vandetanib 300 mg
regimen
Vandetanib (300 mg daily)
analyzed count
231
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0002
arm key
OG001
arm label
Placebo
regimen
Placebo daily
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0003
arm key
OG000
arm label
Vandetanib 300 mg
regimen
Vandetanib (300 mg daily)
analyzed count
104
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0003
arm key
OG001
arm label
Placebo
regimen
Placebo daily
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0004
arm key
OG000
arm label
Vandetanib 300 mg
regimen
Vandetanib (300 mg daily)
analyzed count
231
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0004
arm key
OG001
arm label
Placebo
regimen
Placebo daily
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0005
arm key
OG000
arm label
Vandetanib 300 mg
regimen
Vandetanib (300 mg daily)
analyzed count
231
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
outcome key
om-0005
arm key
OG001
arm label
Placebo
regimen
Placebo daily
analyzed count
100
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00410761-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
harm key
EG000
source section id
NCT00410761-ae
event group key
EG000
event group label
Randomized Treatment Period: Vandetanib 300 mg
serious affected
92
serious at risk
231
other affected
226
other at risk
231
frequency threshold
5
collection period
Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.
event definition
The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
harm key
EG001
source section id
NCT00410761-ae
event group key
EG001
event group label
Randomized Treatment Period: Placebo
serious affected
16
serious at risk
99
other affected
87
other at risk
99
frequency threshold
5
collection period
Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.
event definition
The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
harm key
EG002
source section id
NCT00410761-ae
event group key
EG002
event group label
Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg
serious affected
53
serious at risk
109
other affected
32
other at risk
109
frequency threshold
5
collection period
Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.
event definition
The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
harm key
EG003
source section id
NCT00410761-ae
event group key
EG003
event group label
Open-Label Treatment Period: Placebo/Vandetanib 300 mg
serious affected
36
serious at risk
79
other affected
70
other at risk
79
frequency threshold
5
collection period
Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.
event definition
The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer-lenvima-a86d5f90
nct id
NCT00410761
qol key
qol-0007
source section id
NCT00410761-om-0007
source outcome index
7
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Time to Worsening of Pain (TWP)
measure definition
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.
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice