Thyroid CancerPhase 2NCT00098345
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
A Phase 2 study testing ZD6474 (vandetanib) in people with Thyroid Cancer, run by Genzyme, a Sanofi Company at 6 sites in 2 countries.
Trial summary
The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- ZD6474 (vandetanib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Nov 2004to 19 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced or hereditary medullary thyroid cancer
- Signed informed consent
- One or more measurable lesions
Who cannot join
- Brain metastases or spinal cord compression
- Specific laboratory ranges
- Specific heart problems
- Prior chemotherapy and/or radiation therapy
- Participation in other trials within 30 days
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Research Site
Durham, North Carolina
Research Site
Houston, Texas
Research Site
New Haven, Connecticut
Research Site
New York, New York
Research Site
San Francisco, California
About this study
Official title: An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.
The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.
- Conditions
- Thyroid Cancer
- Being tested
- ZD6474 (vandetanib)
- Keywords
- Caprelsa (vandetanib), ZD6474
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6474 (vandetanib)Drug
Also called Caprelsa™ (vandetanib), SAR390530
oral once daily tablet
| Study group | Role | What they receive |
|---|---|---|
| Caprelsa (vandetanib) 300 mg | Experimental | Daily oral dose of Caprelsa (vandetanib) 300mg Receives: Drug: ZD6474 (vandetanib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
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) defined according to RECIST 1.0.
Measured: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Secondary outcomes (6)
Progression Free Survival
Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
Measured: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Duration of Objective Response
Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.
Measured: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Disease Control Rate
Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.
Measured: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Biochemical Response Calcitonin (CTN)
A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).
Measured: Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation
Symptomatic Response
Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.
Measured: Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.
World Health Organisation (WHO) Performance Status
Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)
Measured: Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2004 (estimated)
- Study startNov 2004
- Primary completionFeb 2008
- Study completion19 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098345
- Sponsor's protocol ID
- D4200C00008
- Other IDs
- LPS14954
- Status last verified
- Apr 2018
- First submitted
- 7 Dec 2004
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wells SA Jr, Gosnell JE, Gagel RF, Moley J, Pfister D, Sosa JA, Skinner M, Krebs A, Vasselli J, Schlumberger M. Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol. 2010 Feb 10;28(5):767-72. doi: 10.1200/JCO.2009.23.6604. Epub 2010 Jan 11.
PubMed 20065189
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.
- ClinicalTrials.gov ID
- NCT00098345
- Acronym / sponsor ID
- D4200C00008
- Conditions
- Thyroid Cancer
- Keywords
- Caprelsa (vandetanib), ZD6474
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 8 Dec 2004 (estimated)
- Results
- Posted 24 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caprelsa (vandetanib) 300 mg | Experimental | Drug: ZD6474 (vandetanib)Daily oral dose of Caprelsa (vandetanib) 300mg |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Locally advanced or hereditary medullary thyroid cancer
- Signed informed consent
- One or more measurable lesions
Key exclusion criteria (5 listed)
- Brain metastases or spinal cord compression
- Specific laboratory ranges
- Specific heart problems
- Prior chemotherapy and/or radiation therapy
- Participation in other trials within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD6474 (vandetanib)Also: Caprelsa™ (vandetanib), SAR390530oral once daily tablet | Drug | Caprelsa (vandetanib) 300 mg |
Primary outcome
Objective Response Rate
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
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) defined according to RECIST 1.0.
6 secondary outcomes
Progression Free Survival
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Duration of Objective Response
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Disease Control Rate
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Biochemical Response Calcitonin (CTN)
Time frame: Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation
Symptomatic Response
Time frame: Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.
World Health Organisation (WHO) Performance Status
Time frame: Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20065189Wells SA Jr, Gosnell JE, Gagel RF, Moley J, Pfister D, Sosa JA, Skinner M, Krebs A, Vasselli J, Schlumberger M. Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol. 2010 Feb 10;28(5):767-72. doi: 10.1200/JCO.2009.23.6604. Epub 2010 Jan 11.
- CSR-D4200C00008.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD6474 (vandetanib) in people with Thyroid Cancer, run by Genzyme, a Sanofi Company at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00098345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.