Carcinoma, Renal CellPhase 2NCT00065572
Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)
A Phase 2 study testing ZD6126 in people with Carcinoma, Renal Cell and Kidney Neoplasms, run by AstraZeneca at 16 sites in United States.
Trial summary
The purpose of this study is to assess the biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Kidney Neoplasms
- What is being tested?
- ZD6126
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 16 sitesUnited States
- Study dates
- Aug 2003to Feb 2004
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed metastatic renal cell carcinoma
- Suitable for nephrectomy
Who cannot join
- Prior chemotherapy, biological therapy or radiation therapy for renal cell carcinoma or within the last 3 years for any other cancer
- Significant cardiac event within 3 months of entry
- Any history of coronary angioplasty or history of myocardial infarction
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Research Site
Baltimore, Maryland
Research Site
Chicago, Illinois
Research Site
Cleveland, Ohio
Research Site
Hackensack, New Jersey
Research Site
Indianapolis, Indiana
Research Site
Lebanon, New Hampshire
Research Site
Los Angeles, California
Research Site
Nashville, Tennessee
Research Site
Newark, Delaware
Research Site
Philadelphia, Pennsylvania
Research Site
Portland, Oregon
Research Site
Rochester, New York
Research Site
Salt Lake City, Utah
Research Site
St Louis, Missouri
Research Site
Tampa, Florida
Research Site
The Bronx, New York
About this study
The purpose of this study is to assess the biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV).
- Conditions
- Carcinoma, Renal Cell, Kidney Neoplasms
- Being tested
- ZD6126, Placebo
- Keywords
- Kidney Cancer, Metastatic, Newly diagnosed renal cell carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6126Drug
PlaceboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2003 (estimated)
- Study startAug 2003
- Primary completionFeb 2004 (estimated)
- Study completionFeb 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065572
- Sponsor's protocol ID
- D2820C00018
- Other IDs
- 6126IL/00018
- Status last verified
- Jan 2011
- First submitted
- 28 Jul 2003
- Last updated
- 26 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)
- ClinicalTrials.gov ID
- NCT00065572
- Acronym / sponsor ID
- D2820C00018
- Conditions
- Carcinoma, Renal Cell, Kidney Neoplasms
- Keywords
- Kidney Cancer, Metastatic, Newly diagnosed renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Feb 2004 (estimated)
- Study completion
- Feb 2004 (estimated)
- First posted
- 31 Jul 2003 (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 biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed metastatic renal cell carcinoma
- Suitable for nephrectomy
Key exclusion criteria (3 listed)
- Prior chemotherapy, biological therapy or radiation therapy for renal cell carcinoma or within the last 3 years for any other cancer
- Significant cardiac event within 3 months of entry
- Any history of coronary angioplasty or history of myocardial infarction
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 |
|---|---|---|
| ZD6126 | Drug | – |
| Placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD6126 in people with Carcinoma, Renal Cell and Kidney Neoplasms, run by AstraZeneca at 16 sites in United States.
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 2 inclusion and 3 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: paused, as of the sponsor's last update on 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Results are not available in the source record.
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 26 Jan 2011.