Non Small Cell Lung CancerPhase 4NCT00762346
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
A Phase 4 study testing zometa in people with Non Small Cell Lung Cancer and Bone Metastases, run by Sun Yat-sen University at 1 site in China.
Trial summary
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Bone Metastases, High NTX Level
- What is being tested?
- zometa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Mar 2013
- Phase
- Phase 4
- 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
- Age > 18
- Histologically confirmed non-small cell cancer
- One bone metastasis at least confirmed by image(X ray, CT or others)
- NTX > 50nM BCE/mM creatinine
- Life expectancy > 6 M
- ECOG <= 2
- Signed ICF
Who cannot join
- Women who are pregnant or in lactation
- Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
- Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
Trial locations and contacts
1 site in 1 country.
About this study
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.
- Conditions
- Non Small Cell Lung Cancer, Bone Metastases, High NTX Level
- Being tested
- zometa
- Keywords
- non small cell lung cancer, NTX, zometa
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zometaDrug
zometa 4mg i.v. every 4 weeks for up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: zometa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeleton-related event
Measured: 2 years
Secondary outcomes (1)
OS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2013
- Study completionMar 2013
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 CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762346
- Sponsor's protocol ID
- CZOL446ECN06T
- Status last verified
- Dec 2011
- First submitted
- 29 Sep 2008
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
- ClinicalTrials.gov ID
- NCT00762346
- Acronym / sponsor ID
- CZOL446ECN06T
- Conditions
- Non Small Cell Lung Cancer, Bone Metastases, High NTX Level
- Keywords
- non small cell lung cancer, NTX, zometa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Sep 2008 (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.
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: zometa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18
- Histologically confirmed non-small cell cancer
- One bone metastasis at least confirmed by image(X ray, CT or others)
- NTX > 50nM BCE/mM creatinine
- Life expectancy > 6 M
Key exclusion criteria (4 listed)
- Women who are pregnant or in lactation
- Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
- Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study -
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 |
|---|---|---|
| zometazometa 4mg i.v. every 4 weeks for up to 2 years | Drug | 1 |
Primary outcome
Skeleton-related event
Time frame: 2 years
1 secondary outcome
OS
Time frame: 2 years
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 10 Dec 2013.
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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.
Li Zhang, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zometa in people with Non Small Cell Lung Cancer and Bone Metastases, run by Sun Yat-sen University 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 7 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 10 Dec 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Skeleton-related event (time frame: 2 years). 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 10 Dec 2013.