Breast NeoplasmsPhase 2NCT00034918
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer
A Phase 2 study testing ZD6474 in people with Breast Neoplasms and Metastases, Neoplasm, run by Genzyme, a Sanofi Company at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Metastases, Neoplasm
- What is being tested?
- ZD6474
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2002to Nov 2003
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological and/or cytological confirmation of metastatic breast cancer which is refractory to anthracycline, taxane, with or without capecitabine therapies;
- WHO performance status 0, 1 or 2 on the day of registration;
- Females, aged >= 18 years;
- No Gastrointestinal pathology which could affect the bioavailability of ZD6474.
Who cannot join
- Any evidence of severe or uncontrolled systemic diseases including known cases of Hepatitis B or C or human immunodeficiency virus (HIV).
- Significant cardiac event (including symptomatic heart failure or unstable angina) within 3 months of entry or any cardiac disease that in the opinion of the investigator increases risk for ventricular arrhythmia;
- History of clinically significant cardiac arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia;
- Chronic atrial fibrillation;
- Previous history of QT / QTc prolongation with other medication;
- Congenital long QT syndrome;
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- Systemic anti-cancer therapy or other investigational agent within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, or suramin);
- Currently receiving drugs with known significant 3A4 inhibitory (ie, ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil) or stimulatory (ie, phenytoin, carbamazepine, barbiturates, rifampicin) effects;
- Currently receiving therapeutic doses of warfarin (Coumadin?)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-label, Multicenter Phase II Study to Assess the Response of Subjects With Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy With or Without Capecitabine to ZD6474 (100-mg or 300-mg Daily Oral Dose).
The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.
- Conditions
- Breast Neoplasms, Metastases, Neoplasm
- Being tested
- ZD6474
- Keywords
- Metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6474Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startMay 2002
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 44 participants
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
- NCT00034918
- Sponsor's protocol ID
- 6474IL/0002
- Status last verified
- Aug 2016
- First submitted
- 2 May 2002
- Last updated
- 24 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase II Study to Assess the Response of Subjects With Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy With or Without Capecitabine to ZD6474 (100-mg or 300-mg Daily Oral Dose).
- ClinicalTrials.gov ID
- NCT00034918
- Acronym / sponsor ID
- 6474IL/0002
- Conditions
- Breast Neoplasms, Metastases, Neoplasm
- Keywords
- Metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Study completion
- Nov 2003 (actual)
- First posted
- 3 May 2002 (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.
The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological and/or cytological confirmation of metastatic breast cancer which is refractory to anthracycline, taxane, with or without capecitabine therapies;
- WHO performance status 0, 1 or 2 on the day of registration;
- Females, aged >= 18 years;
- No Gastrointestinal pathology which could affect the bioavailability of ZD6474.
Key exclusion criteria (9 listed)
- Any evidence of severe or uncontrolled systemic diseases including known cases of Hepatitis B or C or human immunodeficiency virus (HIV).
- Significant cardiac event (including symptomatic heart failure or unstable angina) within 3 months of entry or any cardiac disease that in the opinion of the investigator increases risk for ventricular arrhythmia;
- History of clinically significant cardiac arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia;
- Chronic atrial fibrillation;
- Previous history of QT / QTc prolongation with other medication;
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 | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Aug 2016.
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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
2 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 in people with Breast Neoplasms and Metastases, Neoplasm, run by Genzyme, a Sanofi Company at 2 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 4 inclusion and 9 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 24 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 2 sites in United States, Spain. 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?
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.
Where can I read the original study information?
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 24 Aug 2016.