Advanced Solid, Malignant TumorsPhase 1NCT00503711
Phase I Chinese PK
A Phase 1 study testing Vandetanib and Vandetanib 300 mg in people with Advanced Solid, Malignant Tumors, run by Genzyme, a Sanofi Company at 1 site in China.
Trial summary
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid, Malignant Tumors
- What is being tested?
- Vandetanib and Vandetanib 300 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Sep 2006to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological and/or cytological confirmation of a malignant solid tumor
- refractory to standard therapies or for which no appropriate therapies exist
- WHO performance status 0-2
Who cannot join
- patients with brain tumors or symptomatic cerebral metastases
- systemic anticancer therapy within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Phase I, Rising Multiple Dose, Single Centre Study to Determine the PK and Tolerability of ZD6474 at Different Dose Levels in Chinese Patients With Solid Malignancy Tumor
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.
- Conditions
- Advanced Solid, Malignant Tumors
- Being tested
- Vandetanib, Vandetanib 300 mg
- Keywords
- ZD6474 PK
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VandetanibDrug
Also called ZD6474, ZACTIMA™
100 mg every other day, 100mg once daily
Vandetanib 300 mgDrug
Also called ZD6474, ZACTIMA™
300mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 100 mg Vandetanib eod | Experimental | 100 mg Vandetanib every other day dosing Receives: Drug: Vandetanib |
| 100 mg Vandetanib od | Experimental | 100 mg Vandetanib once daily dosing Receives: Drug: Vandetanib |
| 300 mg Vandetanib od | Experimental | 300 mg Vandetanib once daily dosing Receives: Drug: Vandetanib 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) (0-24) (ng.h/mL) after single dose
Measured: Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startSep 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid, Malignant TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00503711
- Sponsor's protocol ID
- D4200L00004
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2007
- Last updated
- 31 Aug 2016
- Results posted
- No
Publications
Zhang L, Li S, Zhang Y, Zhan J, Zou BY, Smith R, Martin PD, Jiang Y, Liao H, Guan Z. Pharmacokinetics and tolerability of vandetanib in Chinese patients with solid, malignant tumors: an open-label, phase I, rising multiple-dose study. Clin Ther. 2011 Mar;33(3):315-27. doi: 10.1016/j.clinthera.2011.04.005.
PubMed 21600385
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase I, Rising Multiple Dose, Single Centre Study to Determine the PK and Tolerability of ZD6474 at Different Dose Levels in Chinese Patients With Solid Malignancy Tumor
- ClinicalTrials.gov ID
- NCT00503711
- Acronym / sponsor ID
- D4200L00004
- Conditions
- Advanced Solid, Malignant Tumors
- Keywords
- ZD6474 PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100 mg Vandetanib eod | Experimental | Drug: Vandetanib100 mg Vandetanib every other day dosing |
| 100 mg Vandetanib od | Experimental | Drug: Vandetanib100 mg Vandetanib once daily dosing |
| 300 mg Vandetanib od | Experimental | Drug: Vandetanib 300 mg300 mg Vandetanib once daily dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histological and/or cytological confirmation of a malignant solid tumor
- refractory to standard therapies or for which no appropriate therapies exist
- WHO performance status 0-2
Key exclusion criteria (2 listed)
- patients with brain tumors or symptomatic cerebral metastases
- systemic anticancer therapy within the last 4 weeks
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 |
|---|---|---|
| VandetanibAlso: ZD6474, ZACTIMA™100 mg every other day, 100mg once daily | Drug | 100 mg Vandetanib eod, 100 mg Vandetanib od |
| Vandetanib 300 mgAlso: ZD6474, ZACTIMA™300mg once daily | Drug | 300 mg Vandetanib od |
Primary outcome
Area under the curve (AUC) (0-24) (ng.h/mL) after single dose
Time frame: Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Background: PubMed 21600385Zhang L, Li S, Zhang Y, Zhan J, Zou BY, Smith R, Martin PD, Jiang Y, Liao H, Guan Z. Pharmacokinetics and tolerability of vandetanib in Chinese patients with solid, malignant tumors: an open-label, phase I, rising multiple-dose study. Clin Ther. 2011 Mar;33(3):315-27. doi: 10.1016/j.clinthera.2011.04.005.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vandetanib and Vandetanib 300 mg in people with Advanced Solid, Malignant Tumors, run by Genzyme, a Sanofi Company at 1 site in China.
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 2 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the curve (AUC) (0-24) (ng.h/mL) after single dose (time frame: Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1). 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 NCT00503711, 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 31 Aug 2016.