Non-Small Cell Lung CancerPhase 1NCT00970580
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer
A Phase 1 study testing BIIB022 With Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Biogen at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- BIIB022 With Paclitaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 1
- 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 years old
- Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
- ECOG Performance Status 0 or 1
Who cannot join
- History of another primary cancer within 3 years
- Any prior or concurrent investigational or standard therapy for treatment of NSCLC
- Prior anti-IGF-1R therapy
- Unstable diabetes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Resesarch Site
Denver, Colorado
Resesarch Site
Los Angeles, California
Resesarch Site
San Diego, California
About this study
Official title: A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer
The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- BIIB022 With Paclitaxel and Carboplatin
- Keywords
- BIIB022, Stage IV, Taxol, Stage IIIB, Carboplatin, Paclitaxel, Non Small Cell Lung Cancer, Treatment Naive, Anti IGF1R, NSCLC, Open Label, IGF1R, Paraplatin, Cytotoxic, Mitotic Inhibitor, Taxane, Alkylating agent
- 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.
BIIB022 With Paclitaxel and CarboplatinDrug
Also called Taxol, Paraplatin, BIIB022, Taxane
Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin
| Study group | Role | What they receive |
|---|---|---|
| BIIB022 in Combination with Paclitaxel and Carboplatin | Experimental | BIIB022 in Combination with Paclitaxel and Carboplatin Receives: Drug: BIIB022 With Paclitaxel and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionSep 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 BiogenThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970580
- Sponsor's protocol ID
- 212-LC-101
- Status last verified
- Nov 2011
- First submitted
- 1 Sep 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00970580
- Acronym / sponsor ID
- 212-LC-101
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- BIIB022, Stage IV, Taxol, Stage IIIB, Carboplatin, Paclitaxel, Non Small Cell Lung Cancer, Treatment Naive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Sep 2009 (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 determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIIB022 in Combination with Paclitaxel and Carboplatin | Experimental | Drug: BIIB022 With Paclitaxel and CarboplatinBIIB022 in Combination with Paclitaxel and Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >/= 18 years old
- Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
- ECOG Performance Status 0 or 1
Key exclusion criteria (4 listed)
- History of another primary cancer within 3 years
- Any prior or concurrent investigational or standard therapy for treatment of NSCLC
- Prior anti-IGF-1R therapy
- Unstable diabetes
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 |
|---|---|---|
| BIIB022 With Paclitaxel and CarboplatinAlso: Taxol, Paraplatin, BIIB022, TaxaneEscalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin | Drug | BIIB022 in Combination with Paclitaxel and Carboplatin |
Primary outcome
To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin
Time frame: 6 months
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 16 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB022 With Paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer, run by Biogen at 3 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 3 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin (time frame: 6 months). 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 16 Sep 2013.