Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-linePhase 2NCT00047840
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.
A Phase 2 study testing ZD6474 and Docetaxel in people with Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line, run by Genzyme, a Sanofi Company at 26 sites in 3 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
- What is being tested?
- ZD6474 and Docetaxel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Oct 2002to Sep 2006
- 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
- Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
- Failure of first-line platinum-based chemotherapy
Who cannot join
- Mixed small cell or non-small-cell histology
- Bronchoalveolar carcinoma
- Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
- Prior treatment with docetaxel
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States16 sites
Research Site
Ann Arbor, Michigan
Research Site
Atlanta, Georgia
Research Site
Billings, Montana
Research Site
Boston, Massachusetts
Research Site
Coos Bay, Oregon
Research Site
Detroit, Michigan
Research Site
Durham, North Carolina
Research Site
Great Neck, New York
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Los Angeles, California
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Pittsfield, Massachusetts
Czechia6 sites
Research Site
Brno
Research Site
Chomutov
Research Site
Hradec
Research Site
Ostrava
Research Site
Pilsen
Research Site
Prague
Hungary4 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Deszk
Research Site
Törökbálint
About this study
Official title: A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
- Being tested
- ZD6474, Placebo, Docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6474Drug
PlaceboDrug
DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Progression free survival
Secondary outcomes (5)
Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
Objective response rate and duration of response
QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
WHO performance status
Time to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2002 (estimated)
- Study startOct 2002
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-lineStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 129 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
- NCT00047840
- Sponsor's protocol ID
- 6474IL/0006
- Status last verified
- Aug 2016
- First submitted
- 18 Oct 2002
- Last updated
- 25 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
- ClinicalTrials.gov ID
- NCT00047840
- Acronym / sponsor ID
- 6474IL/0006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Oct 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 and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.
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)
- Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
- Failure of first-line platinum-based chemotherapy
Key exclusion criteria (4 listed)
- Mixed small cell or non-small-cell histology
- Bronchoalveolar carcinoma
- Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
- Prior treatment with docetaxel
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 | – |
| Placebo | Drug | – |
| Docetaxel | Drug | – |
Primary outcome
Outcome Progression free survival
5 secondary outcomes
Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
Objective response rate and duration of response
QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
WHO performance status
Time to death
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 25 Aug 2016.
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
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD6474 and Docetaxel in people with Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line, run by Genzyme, a Sanofi Company at 26 sites in 3 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 2 inclusion and 4 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 25 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 26 sites in United States, Czechia, Hungary. 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.
What does the primary outcome measure?
Outcome Progression free survival. It is what the study was designed to measure, not a finding.
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 25 Aug 2016.