Non Small Cell Lung CancerNCT01099124
Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)
A study testing M2ES in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- M2ES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Sep 2011
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years old;
- Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
- No contraindication for chemotherapy;
- ECOG performance scale 0-2;
- No history of anti-angiogenesis therapy;
- Patients are voluntary to participate and sigh the informed contents.
Who cannot join
- Concurrent use of other anti-cancer agents;
- Allergic history to M2ES and biological agents;
- Pregnant or breast-feeding women;
- With other malignancy;
- With severe cardiopulmonary disease;
- Uncontrolled brain metastasis patients;
- Other conditions that are regarded for exclusion by the trialists.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- M2ES
- Keywords
- M2ES, NSCLC, Phase I Trial, Advanced NSCLC, Recurrent NSCLC
- 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.
M2ESDrug
polyethylene glycol rh recombinant endostatin
| Study group | Role | What they receive |
|---|---|---|
| M2ES combined with chemotherapy | Experimental | Not described Receives: Drug: M2ES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events incidence,including severe adverse events incidence
Measured: one year
Secondary outcomes (1)
Tumor response rate and disease controlled rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionSep 2011
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 Tianjin Medical University Cancer Institute and HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai LI, Principal investigator, Tianjin Medical University Cancer Institude and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099124
- Sponsor's protocol ID
- TMU-CIH-CTI-001
- Status last verified
- Apr 2010
- First submitted
- 24 Feb 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC
- ClinicalTrials.gov ID
- NCT01099124
- Acronym / sponsor ID
- TMU-CIH-CTI-001
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- M2ES, NSCLC, Phase I Trial, Advanced NSCLC, Recurrent NSCLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Apr 2010 (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 evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M2ES combined with chemotherapy | Experimental | Drug: M2ES |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-70 years old;
- Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
- No contraindication for chemotherapy;
- ECOG performance scale 0-2;
- No history of anti-angiogenesis therapy;
Key exclusion criteria (7 listed)
- Concurrent use of other anti-cancer agents;
- Allergic history to M2ES and biological agents;
- Pregnant or breast-feeding women;
- With other malignancy;
- With severe cardiopulmonary disease;
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 |
|---|---|---|
| M2ESpolyethylene glycol rh recombinant endostatin | Drug | M2ES combined with chemotherapy |
Primary outcome
Adverse events incidence,including severe adverse events incidence
Time frame: one year
1 secondary outcome
Tumor response rate and disease controlled rate
Time frame: one year
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 29 Jan 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.
Kai LI principal investigator
Tianjin Medical University Cancer Institude and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M2ES in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 6 inclusion and 7 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 29 Jan 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.
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?
Adverse events incidence,including severe adverse events incidence (time frame: one year). 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 29 Jan 2013.