Non-Squamous Non-Small Cell Lung CancerPhase 2NCT00642824
A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
A Phase 2 study testing Standard chemotherapy and bevacizumab [Avastin] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 22 sites in Spain.
Trial summary
This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- Standard chemotherapy and bevacizumab [Avastin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 22 sitesSpain
- Study dates
- May 2007to Dec 2009
- 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
- participating in, and meeting all inclusion/exclusion criteria of, MO19390.
Who cannot join
- not meeting the inclusion/exclusion criteria of MO19390.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Study site
Alcorcón, 28922
Study site
Alcoy, 03804
Study site
Alicante, 03010
Study site
Badalona, 08915
Study site
Barakaldo, 48903
Study site
Burgos, 09005
Study site
Elche, 03203
Study site
Girona, 17007
Study site
Huesca, 22004
Study site
Las Palmas de Gran Canaria, 35016
Study site
Lugo, 27004
Study site
Madrid, 28006
Study site
Madrid, 28040
Study site
Madrid, 28046
Study site
Murcia, 30008
Study site
Palma de Mallorca, 07014
Study site
Pamplona, 31008
Study site
Salamanca, 37007
Study site
San Cristóbal de La Laguna, 38320
Study site
Valencia, 41014
Study site
Valencia, 46009
Study site
Zaragoza, 50009
About this study
Official title: Local Substudy Associated to the International Study MO19390 to Determine the BRCA1 Gene mRNA Expression as a Predictive Marker of Response to Chemotherapy
This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin. A subset of patients participating in MO19390, and receiving Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will receive a different chemotherapy regimen in combination with Avastin: a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 100-500 individuals.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- Standard chemotherapy, bevacizumab [Avastin]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard chemotherapyDrug
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
bevacizumab [Avastin]Drug
15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Standard chemotherapy; Drug: bevacizumab [Avastin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: Event driven
Secondary outcomes (2)
Overall survival; response rates
Measured: Event driven
Adverse events
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Terminated due to low enrollment. No statistical analyses were performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642824
- Sponsor's protocol ID
- ML21150
- Status last verified
- Nov 2016
- First submitted
- 19 Mar 2008
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Substudy Associated to the International Study MO19390 to Determine the BRCA1 Gene mRNA Expression as a Predictive Marker of Response to Chemotherapy
- ClinicalTrials.gov ID
- NCT00642824
- Acronym / sponsor ID
- ML21150
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low enrollment. No statistical analyses were performed.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Mar 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.
This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin. A subset of patients participating in MO19390, and receiving Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will receive a different chemotherapy regimen in combination with Avastin: a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Standard chemotherapy, Drug: bevacizumab [Avastin] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participating in, and meeting all inclusion/exclusion criteria of, MO19390.
Key exclusion criteria (1 listed)
- not meeting the inclusion/exclusion criteria of MO19390.
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 |
|---|---|---|
| Standard chemotherapyAs prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. | Drug | 1 |
| bevacizumab [Avastin]15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks | Drug | 1 |
Primary outcome
Progression-free survival
Time frame: Event driven
2 secondary outcomes
Overall survival; response rates
Time frame: Event driven
Adverse events
Time frame: Throughout study
Results and safety
The study was stopped early (reason given: Terminated due to low enrollment. No statistical analyses were performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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 Trials study director
Hoffmann-La Roche
22 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 Standard chemotherapy and bevacizumab [Avastin] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 22 sites in Spain.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in 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 was stopped early (reason given: Terminated due to low enrollment. No statistical analyses were performed.). 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.
What does the primary outcome measure?
Progression-free survival (time frame: Event driven). 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 2 Nov 2016.